GB/T 10213-2025Single-use medical rubber examination gloves (English PDF)

4.1 Overview

Gloves are classified by category and surface type, see 4.2 and 4.3.

4.2 Categories

a) Category 1.Gloves primarily made from natural rubber latex;

b) Category 2.Gloves primarily made from nitrile rubber latex, chloroprene rubber latex, styrene-butadiene rubber solution, styrene-butadiene rubber emulsion, or thermoplastic elastomer solution.

4.3 Surface type

a) Partially or fully textured gloves;

b) Smooth gloves;

c) Powdered gloves;

Note 1.Powdered gloves are designed for easier donning and typically have powder added during manufacturing. The maximum limit for residual powder on the surface of powdered gloves is 10 mg/piece.

d) Powder-free gloves.

Note 2.Powder-free gloves are gloves to which no powdered material is added during manufacturing. The maximum limit for residual powder on the surface of powder-free gloves is 2.0 mg/piece.

Note 3.Glove cuffs may have straight or curled edges.

6.1 Sampling

During arbitration, gloves shall be sampled and inspected in accordance with the requirements of ISO 2859-1.The inspection levels and acceptance quality limits (AQLs) shall be as specified in Table 1.

When the batch size cannot be determined, a batch size of 35001 ~ 150000 pieces shall be assumed.

6.2 Selection of test pieces

Test pieces shall be cut from the palm or back of the glove.

7.1 Dimensions

When measured at the positions shown in Figure 1, the length and palm width of the glove shall conform to the requirements specified in Table 2.The inspection levels and acceptance quality limits (AQLs) are shown in Table 1.

The length shall be the shortest distance from the tip of the middle finger to the edge of the cuff.

The length can be measured by hanging the glove from a suitable round rod, which has a top radius of 5 mm.

To measure the width, lay the glove flat and measure the distance from the inside of the index finger to the outside of the ring finger. The width is measured midway between the base of the index finger and the base of the thumb.

The double-layer thickness of gloves shall be measured in accordance with ISO 23529, applying a foot pressure of 22 kPa ± 5 kPa. Measurements shall be taken at each location shown in Figure 1.13 mm ± 3 mm from the tip of the middle finger and approximately at the center of the glove palm. Half of the double-layer thickness measured at each point is recorded as the single-layer thickness. Dimensions shall conform to Table 2;

the inspection level and acceptance quality limit (AQL) shall conform to Table 1.

If thin spots are detected during visual inspection, the single-layer thickness shall be measured at these locations. The single-layer thickness of the smooth and textured surfaces, when measured in accordance with this clause, shall be no less than 0.08 mm and 0.11 mm, respectively.

When gloves are tested for waterproofness according to Appendix A. The sample size and the number of gloves permitted to fail (leak) shall be determined according to the inspection level and acceptance quality limit (AQL) in Table 1.

7.3 Tensile properties

7.3.1 General

Tensile properties shall be measured in accordance with ISO 37.Three Type 2 dumbbell specimens shall be cut from each glove; the median value of the test result shall be taken. Specimens shall be cut from the palm or back of the hand.

7.3.2 Breaking strength and elongation at break before accelerated aging

Test according to ISO 37 using Type 2 dumbbell specimens. Breaking strength and elongation at break shall comply with Table 3.The inspection level and acceptance quality limit (AQL) shall comply with Table 1.

7.3.3 Breaking strength and elongation at break after accelerated aging

Accelerated aging tests shall be conducted in accordance with ISO 188.Specimens may be cut from gloves after accelerated aging at (70 ± 2) °C for (168 ± 2) hours, OR they may be cut from gloves and then accelerated aged under the above conditions. Tensile testing shall be conducted in accordance with 7.3.2.The results shall comply with Table

3.The inspection level and acceptance quality limit (AQL) shall comply with Table 1.

Gloves manufactured more than 6 months after their date of production, or whose date of manufacture is unknown, shall not be subjected to accelerated aging testing. Tensile properties shall only comply with the "after accelerated aging" values in Table 3.The

6-month period should be calculated from the first day of the month following the month in which the gloves were manufactured.

7.4 Sterilization

If gloves are sterilized, the type of sterilization treatment shall be marked as required.

9.1 General

Marking shall include a reference to this document. Appropriate symbols from ISO

15223-1 and ISO 15223-2 may be used on the label.

The language used for marking shall be agreed upon by all parties involved.

9.2 Unit packaging

9.2.1 Sterile packaging

A single glove or pair of gloves placed in a bag constitutes a unit packaging. The unit packaging shall be clearly labeled with the following.

a) The manufacturer's or supplier's name or trademark;

b) The material used;

c) "Partially textured or fully textured", "smooth", "powdered", "powder-free", or other terms indicating the glove's surface treatment;

d) Size code/specification;

e) For gloves treated with any surface material, a warning to sterilely remove the surface powder before wearing;

f) The manufacturer's batch number;

g) "Date of manufacture" or similar, the four-digit year, the month of manufacture;

h) Wording that "Sterile, unless package is opened or tampered with";

i) Wording of "Single use" or equivalent;

j) Wording of "Examination gloves";

k) For Category 1 gloves, "Made from natural rubber latex that may cause an allergic reaction" or similar.

9.2.2 Non-sterile packaging

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