(208 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 a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirement of ASTM Standard D5250-06.
Here's a summary of the acceptance criteria and study information for the Weilin Plastic and Rubber Products Co., Ltd. Vinyl Examination Powder Free Gloves, Clear (K123590), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This device is a patient examination glove and its acceptance criteria are based on meeting ASTM Standard D5250-06 and specific FDA requirements for glove integrity and biocompatibility, along with demonstrating substantial equivalence to a predicate device (K992821).
| Acceptance Criteria (from ASTM D5250-06 & FDA) | Reported Device Performance (Weilin Plastic and Rubber Products Co., Ltd.) |
|---|---|
| Physical and Dimensions Testing: | |
| Inspection Level S-2, AQL 2.5 | Meets requirements (implicitly for all physical/dimensional attributes) |
| Before Aging: | |
| Tensile Strength (Mpa) | 16.9 Mpa (Average) |
| Ultimate Elongations | 550% (Average) |
| After Aging: | |
| Tensile Strength (Mpa) | 14.4 Mpa (Average) |
| Ultimate Elongations | 500% (Average) |
| Dimensions (Medium Size): | |
| Overall Length | Average over 230mm |
| Width of Palm | Average 95mm |
| Palm Thickness | Average 0.073 mm |
| Figure Thickness | Average 0.090 mm |
| Residual Powder (ASTM D6124-06): | |
§ 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.