Cleared Traditional

K992031 - LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN)

K992031 is an FDA 510(k) clearance for LATEX EXAMINATION GLOVE POWDER FREE, manufactured by Shanghai Changzheng Latex Factory. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K992031 · Shanghai Changzheng Latex Factory · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
26d
Days
Class 1
Risk

K992031 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRA.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shanghai Changzheng Latex Factory (Sparks, US). The FDA issued a Cleared decision on July 12, 1999 after a review of 26 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shanghai Changzheng Latex Factory devices

FDA 510(k) Submission Details - K992031

510(k) Number K992031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1999
Decision Date July 12, 1999
Days to Decision 26 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
103d faster than avg
Panel avg: 129d · This submission: 26d
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 Peers - LYY Latex Patient Examination Glove

All 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K992031.
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE
K992200 · Shen Wei (Usa), Inc. · Aug 1999
ACCUTOUCH POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
K992428 · Tillotson Healthcare Corp. · Aug 1999
CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K991616 · Hartalega Sdn Bhd · Jul 1999
GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K991554 · Glovco (M) Sdn. Bhd. · Jul 1999
POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES
K991624 · Smart Glove Corp. Sdn Bhd · Jul 1999
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC
K991849 · Seal Polymer Industries Bhd. · Jul 1999