LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)

• K Number: K992018
• Device Name: LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
• Manufacturer: LAGLOVE (M) SDN. BHD.
• Date Cleared: 1999-07-30 ( 44 days)
• Product Code: KGO
• Regulation Number: 878.4460
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powdered), containing 150 ugm or less of water extractable protein per gram is a disposable glove made of Natural Rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

LAGLOVE™ Brand Latex Surgical Gloves - Sterile (Powdered) Containing 150 µgm or less of water Extractable protein per gram.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and study detailed in the request. The document is an FDA 510(k) clearance letter for latex surgical gloves, focusing on regulatory approval and substantial equivalence, not on specific performance acceptance criteria or studies as typically applied to medical devices with measurable outputs like AI algorithms. Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, ground truth, experts, or MRMC studies.

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).