NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES

• K Number: K112693
• Device Name: NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES
• Manufacturer: SGMP CO., LTD.
• Date Cleared: 2012-09-12 ( 363 days)
• Product Code: LYY
• Regulation Number: 880.6250

Intended Use

The Non-Sterile, Powder-Free Yellow Latex Examination Glove With Tutti Flavour and With Protein Labeling Claim of <50 ug/dm² per 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

Non-Sterile, Powder-Free Yellow Latex Examination Gloves With Tutti Frutti Flavour and with Protein Labeling Claim of <50 ug/dm² Per Glove

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a standard examination glove and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.

Therapeutic

No
The device, a latex examination glove, is intended to prevent contamination between patient and examiner, which is a barrier function, not a therapeutic one. It does not treat or alleviate a medical condition.

Diagnostic

No
Explanation: The device is a glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.

SaMD (Software as a Medical Device)

No

The device is a physical glove, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed on samples taken from the body.
• Device Description: The description is of a glove, which is a physical barrier device.
• Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This glove does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Non-Sterile, Powder-Free Yellow Latex Examination Glove With Tutti Flutti Flavour and With Protein Labeling Claim of

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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SGMP Company, Limited
C/O Ms. Janna P. Tucker
Tucker & Associates
198 Avenue De La D'Emerald
Sparks, Nevada 89434

SEP 12 2012

Re: K112693

Trade/Device Name: Non-Sterile, Powder-Free Yellow Latex Examination Gloves with Tutti Frutti Flavour and with Protein Labeling Claim of