Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)

• K Number: K160928
• Device Name: Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)
• Manufacturer: HARTALEGA SDB. BHD.
• Date Cleared: 2016-12-20 ( 260 days)
• Product Code: KGO
• Regulation Number: 878.4460
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim of 50 Microgram or Less per Gram of Glove (Natural) is made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Latex Polymer Coated Powder Free Surgical Glove With Protein Labeling Claim of 50 Microgram or Less per Gram of Glove (Green) is made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for surgical gloves, not a study report for an AI/ML powered medical device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and a study proving a device meets those criteria for an AI-enabled device.

The provided text discusses:

• The FDA's decision to deem Hartalega Sdb. Bhd.'s Latex Polymer Coated Powder Free Surgical Gloves (Natural and Green) as substantially equivalent to legally marketed predicate devices.
• Regulatory information such as the regulation number, class, and product code.
• General controls provisions of the Act that apply to the device.
• Contact information for FDA divisions.
• Indications for Use for both natural and green versions of the surgical gloves, stating they are "intended to be worn by operating room personnel to protect a surgical wound from contamination."
• The type of use as "Over-The-Counter Use."

None of the requested information regarding AI/ML device performance, study design, ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies for an AI/ML device can be extracted from this document.

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).