Cleared Traditional

K150612 - Annuy Latex Patient Examination Glove (powdered and powder-free)

Also marketed or referenced as:
Annuy Nitrile Patient Examination Glove (powdered and powder-free)

K150612 is an FDA 510(k) clearance for Annuy Latex Patient Examination Glove (..., manufactured by Anhui Anyu Latex Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K150612 · Anhui Anyu Latex Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2015
Decision
251d
Days
Class 1
Risk

K150612 is an FDA 510(k) clearance for the Annuy Latex Patient Examination Glove (powdered and powder-free). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Anhui Anyu Latex Products Co., Ltd. (Bengbu, CN). The FDA issued a Cleared decision on November 16, 2015 after a review of 251 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K150612

510(k) Number K150612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2015
Decision Date November 16, 2015
Days to Decision 251 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 129d · This submission: 251d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Shanghai CV Technology Co., Ltd.
DORIS DONG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LYY Latex Patient Examination Glove

All 939
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K150612.
A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
K153744 · A1 Glove Sdn Bhd · Aug 2016
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
K161006 · Hartalega Sdn Bhd · Aug 2016
LATEX EXAMINATION GLOVE POWDER FREE
K152593 · Careplus (M) Sdn Bhd · Feb 2016
MCARE PF POWDER FREE LATEX EXAMINATION HIGH RISK GLOVES
K141042 · Mercator Medical (Thailand), Ltd. · Mar 2015
Patient Examination Gloves
K143419 · Hartalega NGC Sdn. Bhd. · Mar 2015
LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE
K142270 · Hartalega Sdb. Bhd. · Nov 2014