SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES

• K Number: K993859
• Device Name: SHANGHAI GLOVMAX ENTERPRISE CO., LTD. PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
• Manufacturer: SHANGHAI GLOVMAX ENTERPRISE CO.,LTD
• Date Cleared: 2000-01-12 ( 58 days)
• Product Code: LYZ
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: K984461

Intended Use

A glove 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 on the examiner's hand or finger to prevent contamination between patient and examiner.

Device Description

Classified by FDA's General and Plastic Surgery Device Panel as Class I, 21 CFR 880.6250, Pre-powder Vinyl Patient Examination Glove, 80LYZ , powdered with Absorbable Dusting Powder, USP, Class III and meets all requirements of ASTM Standard D5250-92.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard / Test)	Performance Requirement	Reported Device Performance
ASTM D-5250-92 (Physical and Dimensions Testing)	All requirements stated in ASTM D-5250-92	Meets all requirements
FDA 1000 ml. Water Fill Test	AQL 2.5, Inspection Level S-4	Meets requirements
Primary Skin Irritation	No primary skin irritant reactions	No primary skin irritant reactions
Skin Sensitization (Allergic Contact Dermatitis)	No sensitization reactions	No sensitization reactions
Pinholes	Meets FDA requirements	Meets FDA requirements
Biocompatibility	N/A (implied by skin irritation/sensitization tests)	Meets requirements
Labeling Claims	N/A (no special claims, not hypoallergenic)	Conforms to claims
GMP Compliance	Compliance with FDA's GMPs	Operates in compliance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Test Sets for Physical and Dimensions, Water Fill Test:
     • Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. The exact sample size n would depend on the batch size, as per ASTM sampling tables for Inspection Level S-2.
     • FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level S-4. The exact sample size n would depend on the batch size, as per FDA or ASTM sampling tables for Inspection Level S-4.
   • Test Sets for Primary Skin Irritation and Skin Sensitization: Not specified, but "samplings" were used.
   • Data Provenance: Not explicitly stated, but the company is based in Shanghai, China, suggesting the testing was performed on products manufactured there. It is a retrospective summary of tests performed to demonstrate compliance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for these tests is based on objective measurements against established standards (ASTM D-5250-92, FDA water fill test criteria) and biological testing protocols for skin irritation/sensitization, not expert consensus on interpretations of images or findings.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The tests involve direct measurement against defined physical or biological criteria.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a pre-powdered vinyl examination glove, not an AI-powered diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Physical and Dimensions: Objective measurements compared against the specifications defined in ASTM D-5250-92.
   • Water Fill Test (Pinhole): Objective observation of water leakage, compared against the acceptance criteria (AQL 2.5).
   • Primary Skin Irritation and Skin Sensitization: Biological responses (e.g., skin reactions) observed in tested subjects (likely animals or human volunteers for patch tests), against predefined criteria for irritant or sensitizing reactions.

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

8. How the ground truth for the training set was established: Not applicable. This is not a machine learning or AI device.

Regulation Number and Section

§ 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.