(122 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or lingers to prevent contamination between patient and examiner.
White Vinyl Exam Gloves Powder Free is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers 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. 80LYZ. and meets all requirement of ASTM Standard D5250-06.
The provided document is a 510(k) summary for the "White Vinyl Exam Gloves Powder Free." This is a medical device application for approval based on substantial equivalence to an already marketed predicate device, not a clinical study report for an artificial intelligence or diagnostic device. Therefore, many of the requested elements are not applicable to this type of submission.
However, I can extract the acceptance criteria and performance data as presented for the non-clinical tests conducted to demonstrate substantial equivalence of the proposed device to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (medical gloves), the "acceptance criteria" are typically defined by recognized standards (like ASTM D5250-06) and the performance of the predicate device. The "device performance" refers to the results obtained from testing the proposed device against these standards and in comparison to the predicate.
| Characteristic | Acceptance Criteria (from ASTM D5250-06 and/or Predicate) | Proposed Device Performance (Shandong Dawei Medical Products Co., Ltd. White Vinyl Exam Gloves Powder Free) |
|---|---|---|
| Before Aging: Tensile Strength (Mpa) | Average Tensile Strength (Mpa): 16.80 (Predicate) | Average Tensile Strength (Mpa): 16.84 |
| Before Aging: Ultimate Elongations | Average Ultimate Elongations: 510% (Predicate) | Average Ultimate Elongations: 520% |
| After Aging: Tensile Strength (Mpa) | Average Tensile Strength (Mpa): 15 (Predicate) | Average Tensile Strength (Mpa): 14.96 |
| After Aging: Ultimate Elongations | Average Ultimate Elongations: 480% (Predicate) | Average Ultimate Elongations: 481% |
| Overall Length on Medium Size | Average over 232mm (Predicate) | Average over 232.23mm |
| Width of Palm on Medium Size | Average 96mm (Predicate) | Average 95mm |
| Palm Thickness | Average 0.096 mm (Predicate) | Average 0.095 mm |
| Figure Thickness | Average 0.091 mm (Predicate) | Average 0.090 mm |
| Residual Powder |
§ 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.