(96 days)
The Medical nitrile examination gloves (Model: SH001) is intended to be worn on the hands of examiners to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
The subject device is a powder-free nitrile examination glove, provided as a non-sterile and disposable device. The subject device is mainly made from nitrile and there are four sizes, includes small (S), medium (M), large (L), X-large (XL) for optional. The gloves are provided with blue color, the colorant is Butadiene-Acrylonitrile Copolymers (CAS No.9003-18-3) and Pigment Blue (CAS No.147-14-8). The examination glove is a smooth surface with textured fingertips and a rolled rim at the cuff edge. The Medical nitrile examination gloves meet the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The provided text describes the acceptance criteria and performance data for "Medical nitrile examination gloves (Model: SH001)" to demonstrate substantial equivalence to a predicate device for FDA 510(k) clearance. This is a Class I medical device and the data provided is for non-clinical performance testing, primarily mechanical and biocompatibility tests, not an AI/Software-as-a-Medical-Device (SaMD) study.
Therefore, many of the requested items related to AI/SaMD studies (e.g., human-in-the-loop performance, expert ground truth, adjudication methods, multi-reader multi-case studies, training/test set sample sizes for AI, etc.) are not applicable to this submission focusing on physical product characteristics of examination gloves.
I will provide the information that is applicable from the provided text.
Acceptance Criteria and Device Performance for Medical Nitrile Examination Gloves (Model: SH001)
The device, Medical nitrile examination gloves (Model: SH001), underwent non-clinical performance testing to demonstrate its safety and effectiveness, primarily adhering to the ASTM D6319-19 standard. The study aimed to show substantial equivalence to a predicate device (K203593).
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method (Standard) | Test Purpose | Acceptance Criteria | Reported Device Performance (Test Results) | Conclusion |
|---|---|---|---|---|
| ASTM D6319-19 - Physical Dimensions Test | To determine the width, length, and thickness of the gloves | Width: | ||
| S: 80±10 mm | ||||
| M: 95±10 mm | ||||
| L: 110±10 mm | ||||
| XL: 120±10 mm | ||||
| Length: | ||||
| S: ≥220 mm | ||||
| M/L/XL: ≥230 mm | Lot Batch 20210723C1: | |||
| Width: S: 79-84mm, M: 93-97mm, L: 104-107mm, XL: 112-115mm | ||||
| Length: S: 231-235mm, M: 234-238mm, L: 237-240mm, XL: 238-243mm | ||||
| Lot Batch 20210719A1: | ||||
| Width: S: 80-83mm, M: 93-96mm, L: 104-107mm, XL: 112-116mm | ||||
| Length: S: 231-235mm, M: 235-238mm, L: 237-240mm, XL: 239-243mm | ||||
| Lot Batch 20210726A0: | ||||
| Width: S: 79-83mm, M: 94-97mm, L: 104-107mm, XL: 112-116mm | ||||
| Length: S: 232-235mm, M: 235-238mm, L: 237-240mm, XL: 238-243mm | Passed (for all 3 lots) | |||
| ASTM D6319-19 - Thickness Test | To determine the thickness of the gloves | Finger: ≥0.05mm | ||
| Palm: ≥0.05mm | For all three lots (S/M/L/XL): Finger min: 0.13mm, Palm min: 0.13mm | Passed (for all 3 lots) | ||
| ASTM D6319-19 - Physical Properties (Tensile Strength & Ultimate Elongation) | To determine tensile strength and ultimate elongation before and after accelerated aging | Before Aging: | ||
| Tensile Strength: ≥14Mpa | ||||
| Ultimate Elongation: ≥500% | ||||
| After Aging: | ||||
| Tensile Strength: ≥14Mpa | ||||
| Ultimate Elongation: ≥400% | For all three lots: | |||
| Before Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥500% | ||||
| After Aging: Tensile Strength: ≥14Mpa, Ultimate Elongation: ≥400% | Passed (for all 3 lots) | |||
| ASTM D6319-19 (ASTM D5151-11) - Freedom from Holes (Water Tight) | To determine the holes in the gloves | AQL 2.5 | For all three lots: Pass at AQL 2.5 | Passed (for all 3 lots) |
| ASTM D6319-19 (ASTM D6124-11) - Residual Powder | To determine the residual powder in the gloves |
§ 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.