(55 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00a1.
The provided document is a 510(k) summary for Shijiazhuang Great Vision Plastics Products Co., Ltd. Powder Free (Blue) Nitrile Patient Examination Gloves. This product is a Medical Device, not an AI/ML device. Therefore, the specific information requested about acceptance criteria, study details, and AI/ML specific aspects (like multi-reader multi-case studies, standalone performance, training/test sets, and ground truth establishment) is not applicable to this submission.
However, I can extract the acceptance criteria and the results of the non-clinical tests performed to demonstrate substantial equivalence, which is the analogous information for this type of device.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria / Test Performed | Standard / Requirement | Reported Device Performance / Result |
|---|---|---|
| Physical and Dimensions Testing (for glove production) | ASTM-D-6319-00a1, Inspection Level S-2, AQL 4.0 | Meets all requirements |
| FDA 1000 mL Water Fill Test (for pinholes) | AQL 2.5, Inspection Level G-1 | Meets these requirements |
| Primary Skin Irritation | N/A (implied standard for biocompatibility) | No primary skin irritant |
| Skin Sensitization (allergic contact dermatitis) | N/A (implied standard for biocompatibility) | No sensitization reactions |
| Residual Powder Test (for "powder-free" claim) | ASTM D6124-01 (for Starch), |
§ 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.