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Annuy Latex and Nitrile Patient Examination Glove (Powdered and Powder-Free)

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K150612

by Anhui Anyu Latex Products Co., Ltd

Identifiers

510(k) Number
K150612 FDA 510(k)
FDA Product Code
LYY FDA 510(k)
Models / Variants
Annuy Latex Patient Examination Glove (powdered and powder-free) FDA 510(k)EUDAMED
Annuy Nitrile Patient Examination Glove (powdered and powder-free) FDA 510(k)EUDAMED

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 880.6250 FDA 510(k)
Regulation Number
880.6250 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Annuy Latex and Nitrile Patient Examination Glove is a disposable barrier device classified as a patient examination glove. It is designed to prevent contamination between the examiner and patient during medical procedures, ensuring hygiene and reducing cross-transmission of pathogens.

These gloves are supplied in powdered and powder-free variants, intended for single-use in clinical, hospital, or outpatient settings. They comply with FDA 510(k) clearance (K150612), European Medical Device Directive (MDD), and Medical Device Regulation (MDR). Sterility and material composition (latex or nitrile) are specified per variant, with no reusable or MRI-compatible indications stated.

Frequently asked questions

Are these gloves suitable for reuse in any capacity, or are they strictly single-use only?

These gloves are explicitly designed for single-use only and must not be reused. The product description and classification as a disposable barrier device emphasize their intended one-time use to prevent contamination and ensure hygiene during medical procedures.

What materials are these gloves made from, and how does that affect their use?

The gloves come in two material variants: latex and nitrile. Latex gloves may cause allergic reactions in sensitive individuals, while nitrile gloves are a synthetic alternative that avoids latex allergens. Both variants are available in powdered and powder-free versions, with powder-free options reducing the risk of powder-related irritation or contamination.

How should I store these gloves to maintain their integrity and sterility?

Since these gloves are sterile and intended for single-use, they should be stored in their original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants, as this could compromise sterility or material integrity before use.

Are these gloves approved for use in all clinical settings, or are there specific restrictions?

These gloves are FDA 510(k)-cleared (K150612) and comply with European regulations (MDD and MDR), making them suitable for general clinical, hospital, or outpatient use. However, they are not labeled for MRI compatibility or reusable applications, so their use should align strictly with single-use medical procedures.

What size options are available for these gloves, and how do I determine the correct fit?

The product specifications do not detail exact size ranges, but typical patient examination gloves in this category generally include standard sizes (e.g., small, medium, large, extra-large) to accommodate most users. Fit depends on manufacturer guidelines, which may recommend measuring hand circumference or comparing to standard sizing charts—though specific sizing instructions would require consulting the manufacturer’s packaging or documentation.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy ..., Annuy Latex Patient Examination Glove (powdered And Powder-free); Annuy ..., Annuy Latex Patient Examination Glove (powdered and powder-free); Annuy ..., AccessGUDID - DEVICE: Annuy Powder-free Latex Patient Examination Glove ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Anhui Anyu Latex Products Co., Ltd
FDA Applicant
Anhui Anyu Latex Products Co., Ltd.

Sources (2)

  • FDA 510(k) K150612 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced Jun 18, 2026