SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES

• K Number: K021000
• Device Name: SHANGHAI GLOVMAX ENTERPRISE POWDERED BLUE NITRILE EXAMINATION GLOVES
• Manufacturer: SHANGHAI GLOVMAX ENTERPRISE CO.,LTD
• Date Cleared: 2002-05-31 ( 64 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

A powdered patient examintaion glove is a disposable device made of natural nubber latex of in for Indications for USE. A powdered patient camming and is intended to be worn on the hand or fingers (s) for synthell material that bears powder to facilities don't is neemals and other conteminants.

Device Description

A powdered patient examintaion glove is a disposable device made of natural nubber latex of in for Indications for USE. A powdered patient camming and is intended to be worn on the hand or fingers (s) for synthell material that bears powder to facilities don't is neemals and other conteminants.

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML medical device. The document is a 510(k) premarket notification letter from the FDA for "Shanghai Glovmax Enterprise Powdered Blue Nitrile Examination Glove," which is a personal protective equipment (PPE) device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance, and expert details for a test set.
3. Adjudication method for a test set.
4. MRMC comparative effectiveness study details.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Sample size for the training set.
8. How ground truth for the training set was established.

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.