(86 days)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
White Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
The provided document describes the acceptance criteria and performance data for the "White Nitrile Powder-Free Patient Examination Glove, Non Sterile" (K222713). This medical device is a patient examination glove and the testing performed aligns with engineering and material specifications, rather than AI/software performance. Therefore, many of the requested fields related to AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, and training set information) are not applicable to this submission.
Here's the relevant information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Test Method | Acceptance Criteria | Reported Device Performance (K222713) | Status |
|---|---|---|---|---|
| Physical Properties | ASTM D412 (Vulcanized Rubber and Thermoplastic Elastomers—Tension) | Tensile Strength: Before aging: Min 14.0 MPa; After aging: Min 14.0 MPa | ||
| Ultimate Elongation: Before aging: Min 500%; After aging: Min 400% | Tensile Strength: | |||
| Before aging: XS – 28.8 MPa, S – 28.6 MPa, M – 28.9 MPa, L – 28.1 MPa, XL – 28.7 MPa | ||||
| After aging: XS – 30.8 MPa, S – 31.1 MPa, M – 31.8 MPa, L – 31.9 MPa, XL – 30.8 MPa | ||||
| Ultimate Elongation: | ||||
| Before aging: XS – 540%, S – 540%, M – 530%, L – 540%, XL – 540% | ||||
| After aging: XS – 460%, S – 480%, M – 480%, L – 480%, XL – 480% | Pass | |||
| Dimension | ASTM D3767 (Rubber—Measurement of Dimensions) | Length: Min 240 mm | ||
| Width: | ||||
| XS: 70 ± 10 mm | ||||
| S: 80 ± 10 mm | ||||
| M: 95 ± 10 mm | ||||
| L: 110 ± 10 mm | ||||
| XL: 120 ± 10 mm | ||||
| Thickness (Finger & Palm): Min 0.05 mm | Length: | |||
| XS: 248 mm, S: 245 mm, M: 244 mm, L: 248 mm, XL: 244 mm | ||||
| Width: | ||||
| XS: 75 mm, S: 85 mm, M: 95 mm, L: 106 mm, XL: 116 mm | ||||
| Thickness: | ||||
| Finger: 0.09 mm (all sizes) | ||||
| Palm: 0.06 mm (all sizes) | Pass | |||
| Watertight | ASTM D5151 (Detection of Holes in Medical Gloves) | Sample size: 315 pcs (Inspection level G1, AQL 1.5, Acceptance No. 10) | Results for 315 pieces (Batch size 150,001 to 500,000): | |
| XS: 1 piece with leaks | ||||
| S: 2 pieces with leaks | ||||
| M: 2 pieces with leaks | ||||
| L: 4 pieces with leaks | ||||
| XL: 3 pieces with leaks | ||||
| (All within the acceptance criteria of 10 leaks or less for the sample size.) | Pass | |||
| Residual Powder | ASTM D6124 (Residual Powder on Medical Gloves) | Less than 2 mg per glove ( |
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.