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Designation: D 5250 – 00
Standard Specification for
Poly(vinyl chloride) Gloves for Medical Application1 This standard is issued under the fixed designation D 5250; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope U.S. Pharmacopeia for absorbable dusting powder may be
1.1 This specification provides certain requirements for applied to the glove. Other lubricants may be used if their poly(vinyl chloride) gloves used in conducting medical exami- safety and efficacy have been previously established. nations and diagnostic and therapeutic procedures. It also 3.3 The inside and outside surface of the poly(vinyl chlo- covers poly(vinyl chloride) gloves used in handling contami- ride) examination gloves shall be free of talc. nated medical material. 4. Significance and Use 1.2 This specification provides for poly(vinyl chloride) gloves that fit either hand, paired gloves, and gloves by size. It 4.1 The specification is intended as a referee procedure for also provides for packaged sterile or nonsterile or bulk non- evaluating the performance and safety of poly(vinyl chloride) sterile poly(vinyl chloride) gloves. examination gloves. It is not intended for testing prior to 1.3 This specification does not cover two-dimensional heat routine lot release. The safe and proper use of poly(vinyl sealed poly(vinyl chloride) gloves. chloride) examination gloves is beyond the scope of this 1.4 This specification is similar to that of Specification standard. D 3578 for rubber examination gloves. 5. Performance 2. Referenced Documents 5.1 Gloves, sampled in accordance with Section 6, shall 2.1 ASTM Standards: meet the following referee performance requirements: D 412 Test Method for Vulcanized Rubbers and Thermo- 5.1.1 Comply with requirements for sterility when tested in plastic Rubbers and Thermoplastic Elastomers—Tension2 accordance with 7.2. D 573 Test Method for Rubber—Deterioration in an Air 5.1.2 Be free from holes when tested in accordance with 7.3. Oven2 5.1.3 Have consistent physical dimensions in accordance D 3578 Specification for Rubber Examination Gloves3 with 7.4. D 3767 Practice for Rubber—Measurement of Dimensions2 5.1.4 Have acceptable physical property characteristics in D 5151 Test Method for Detection of Holes in Medical accordance with 7.5. Gloves3 5.1.5 Have a powder residue limit in accordance with 7.6. D 6124 Test Method for Residual Powder on Medical 5.1.6 Have a recommended maximum powder limit in Gloves3 accordance with 7.7. 2.2 Other Document: 6. Sampling ISO 2859 Sampling Procedures and Tables for Inspection by Attributes4 6.1 For referee purposes, gloves shall be sampled from U. S. Pharmacopeia5 finished product, after sterilization, and inspected in accor- dance with ISO 2859. The inspection levels and acceptable 3. Materials quality levels (AQL) shall conform to those specified in Table 3.1 Any poly(vinyl chloride) polymer compound may be 1, or as agreed upon between the purchaser and seller, if the used that permits the glove to meet the requirements of this latter is more comprehensive. standard. 7. Referee Test Methods 3.2 A lubricant that meets the current requirements of the 7.1 The following tests shall be conducted to ensure the requirements of Section 8, as prescribed in Table 1: 1 This specification is under the jurisdiction of Committee D-11 on Rubber and 7.2 Sterility Test— Testing for sterility shall be conducted in is the direct responsibility of Subcommittee D11.40 on Consumer Rubber Products. Current edition approved Jan. 10, 2000. Published February 2000. Originally accordance with the latest edition of The U.S. Pharmacopeia. published as D 5250-92. Last previous edition D 5250-99e1. 7.3 Freedom from Holes—Testing for freedom from holes 2 Annual Book of ASTM Standards, Vol 09.01. shall be conducted in accordance with Test Method D 5151. 3 Annual Book of ASTM Standards, Vol 09.02. 7.4 Physical Dimensions Test: 4 Available from American National Standards Institute, 11 W. 42nd St., 13th Floor, New York, NY 10036. 7.4.1 The gloves shall comply with the dimension require- 5 U.S. Pharmacopeia, latest edition, Mack Publishing Co., Easton, PA, 19175. ments prescribed in Table 2.
1 D 5250 TABLE 1 Performance Requirements 8.2 Retests or reinspections are permissible under the pro- Inspection Acceptable visions of the U.S. Pharmacopeia and ISO 2859. Characteristic Related Defects Quality Level Levels A 9. Packaging and Package Marking Sterility falls sterility N/A Freedom from holes holes I 2.5 9.1 Sterile Packaging: Dimensions width, length, and S-2 4.0 9.1.1 The unit of packaging shall normally be one glove or thickness Physical before aging, after S-2 4.0 one pair of gloves. requirements accelerated aging 9.1.2 A glove or pair of gloves, normally, shall be enclosed Powder Free Exceeds Maximum Limit N55 N/A Residue in an inner wallet or wrapper. The wrapper shall be of sufficient Powder Amount Exceeds Recommended N52 N/A size when opened to provide a field for glove-donning pur- Maximum Limit poses. A See U.S. Pharmacopeia. 9.1.3 The glove or pair, and accompanying wrapper if utilized, shall be totally enclosed in an outer package that will 7.4.2 The length shall be expressed in millimetres as mea- allow sterilization of the product. sured from the tip of the second finger to the outside edge of 9.1.4 The outer package shall have a method of closure the cuff. sufficient to ensure the sterility of the product until opened or 7.4.3 The width of the palm shall be expressed in millime- damaged. tres as measured at a level between the base of the index finger 9.1.5 The outer package shall have sufficient strength and and the base of the thumb. Values of width per size other than integrity to withstand normal transportation and storage within listed shall meet the stated tolerance specified in Table 2. the intermediate or shipping cartons, or both. 7.4.4 The minimum thickness shall be expressed in milli- 9.1.6 The method of closure of the outer package shall be metres as specified in Table 2 when using a dial micrometer such that prior opening will be detectable by the user. described in Test Methods D 412, and in the locations indicated 9.1.7 None of the packaging material shall contain any in Fig. 1. For referee tests, cutting the glove is necessary to material likely to impair the quality and use of the gloves. obtain single-thickness measurements. (See Practice D 3767 9.1.8 Intermediate cartons and shipping cases shall be of for more information.) sufficient strength to maintain the quality and sterility of the 7.5 Physical Requirements Test: product during normal transportation and storage. 7.5.1 Before and after accelerated aging, the gloves shall 9.2 Nonsterile and Bulk Packaging: conform to the physical requirements specified in Table 3. 9.2.1 The unit of packaging shall normally be more than one Tests shall be conducted as specified in Test Methods D 412. glove and of a specific amount. 7.5.2 Accelerated aging tests shall be conducted on samples 9.2.2 The gloves shall be enclosed in an outer package that cut from the glove in accordance with Test Method D 573 by has sufficient strength to withstand normal transportation and exposing the glove to 70 6 2°C for 72 6 2 h. The glove shall storage within the cartons or shipping cases, or both. withstand these conditions without evidence of tackiness, 9.2.3 None of the packaging material shall contain any exudation, or other deterioration. material likely to impair the quality and use of the gloves. 7.6 Powder Free Gloves: 7.6.1 The powder residue shall not exceed the average 9.2.4 Cartons and shipping cases shall be of sufficient powder mass and schedule referenced in Annex A1 when tested strength to maintain the quality of the product during normal in accordance with Test Method D 6124. transportation and storage. 7.7 Powdered Gloves: 9.3 Package Marking: 7.7.1 The amount of powder shall not exceed the recom- 9.3.1 Sterile packages shall bear markings for the contents mended average powder mass schedule referenced in Annex to include the glove size, instructions for opening, the legend A2 when tested in accordance with Test Method D 6124 for “sterile,” and a manufacturing lot number. powdered gloves. 9.3.2 Nonsterile and bulk packages shall bear markings for 7.7.2 Determine the square decimeters for the glove size as the contents to include the glove size and a manufacturing lot in 7.7.3 in Specificiation D 3578. number. 9.3.3 The outermost case shall be labeled with the glove size 8. Acceptance and a manufacturing lot number. Sterile product cases shall 8.1 Gloves will be considered to meet the referee perfor- also be marked with the legend “sterile.” mance requirements when test results conform to the require- 9.3.4 All levels of packaging shall conform to all appropri- ments prescribed in Table 3. ate government labeling regulations.
Width by small, medium, large, and extra small medium large x-large 5 large, mm 85 95 105 115 Length, mm 230 for all sizes min Thickness, mm Finger 0.05 min Palm 0.08 min
TABLE 3 Physical Requirements
Tensile Strength, MPa, Ultimate Elongation,% , min min 9 300
ANNEXES
(Mandatory Information)
A1. Powder Residue
A1.1 Average Powder Mass Limit: The limit is not more with the following reduction schedule. than 4.0 milligrams and is reduced by 1.0 milligram each year A1.1.1 Average Powder Mass Limit Reduction Schedule: until a final limit of not more than 2.0 milligrams is achieved
3 D 5250 4.0 milligrams upon publication as an ASTM standard ASTM standard separate. separate (a separate is the final published version of the 2.0 milligrams after the second year of publication of the standard). ASTM standard separate. 3.0 milligram for the second year after the publication of the
A2. POWDER AMOUNT
A2.1 Average Powder Mass—The recommended limit is 20 milligrams per square decimeter upon publication as not more than 20 mg per square decimeter and is reduced by 5 an ASTM standard separate (a separate is the final pub- lished version of the standard). mg each year until a final recommended limit of not more than 10 mg per square decimeter is achieved with the following 15 milligrams per square decimeter for the second year reduction schedule. after the publication of the ASTM standard separate.
A2.1.1 Average Powder Mass Recommended Limit Reduc- 10 milligrams per square decimeter after the second tion Schedule: year of publication of the ASTM standard separate.
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