(40 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
Violet Nitrile Powder-Free Patient Examination Glove, Non-Sterile meets all requirements of ASTM D6319 standard and FDA 21 CFR 880.6250. The powder free nitrile examination glove 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 with ease 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 text describes the acceptance criteria and performance data for a medical device: "Violet Nitrile Powder Free Patient Examination Glove, Non Sterile" (K222721). This is a physical product, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," or "sample size for the training set," are not applicable.
Here's the relevant information based on the provided text, primarily derived from the "Summary of Non-Clinical Testing" (Section 7.0) and "Comparison of the Technological Characteristics of the Device" (Table 1):
1. A table of acceptance criteria and the reported device performance
| Test Method (Standard) | Purpose of Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Physical Properties (ASTM D412) | To evaluate the tensile (tension) properties of glove. | ||
| - Tensile Strength (Before Aging) | Min 14.0 MPa | XS – 28.8 MPa; S – 29.2 MPa; M – 28.0 MPa; L – 27.2 MPa; XL – 26.8 MPa | |
| - Tensile Strength (After Aging) | Min 14.0 MPa | XS – 30.8 MPa; S – 32.2 MPa; M – 31.0 MPa; L – 31.6 MPa; XL – 30.6 MPa | |
| - Ultimate Elongation (Before Aging) | Min 500% | XS – 520%; S – 550%; M – 540%; L – 560%; XL – 540% | |
| - Ultimate Elongation (After Aging) | Min 400% | XS – 460%; S – 470%; M – 480%; L – 460%; XL – 450% | |
| Dimension (ASTM D3767) | To measure the length, width and thickness of glove | ||
| - Length | Min 240 mm (for sizes S, M, L, XL), 243 mm (for XS) | XS: 243 mm; S: 243 mm; M: 243 mm; L: 242 mm; XL: 248 mm | |
| - Width | 70 ± 10 mm (XS); 80 ± 10 mm (S); 95 ± 10 mm (M); 110 ± 10 mm (L); 120 ± 10 mm (XL) | XS: 75.0 mm; S: 85.0 mm; M: 95.0 mm; L: 106 mm; XL: 115 mm | |
| - Finger Thickness | Min 0.05 mm | XS: 0.10 mm; S: 0.10 mm; M: 0.10 mm; L: 0.10 mm; XL: 0.10 mm | |
| - Palm Thickness | Min 0.05 mm | XS: 0.06 mm; S: 0.06 mm; M: 0.06 mm; L: 0.06 mm; XL: 0.06 mm | |
| Watertight (ASTM D5151) | To detect holes that leak water | Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | For Size XS: 3 pieces with leaks; For Size S: 1 piece with leaks; For Size M: 2 pieces with leaks; For Size L: 2 pieces with leaks; For Size XL: 1 piece with leaks. All these results fall within the acceptance criteria. |
| Residual Powder (ASTM D6124) | To determine the amount of residual powder | 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.