Cleared Traditional

K992200 - TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE

K992200 is an FDA 510(k) clearance for TEXTURED POWDER-FREE LATEX EXAMINATION ..., manufactured by Shen Wei (Usa), Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K992200 · Shen Wei (Usa), Inc. · General Hospital
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Aug 1999
Decision
48d
Days
Class 1
Risk

K992200 is an FDA 510(k) clearance for the TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS .... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on August 17, 1999 after a review of 48 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 Shen Wei (Usa), Inc. devices

FDA 510(k) Submission Details - K992200

510(k) Number K992200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1999
Decision Date August 17, 1999
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 129d · This submission: 48d
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 638
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K992200.
LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)
K991777 · Seltom Pacific Sdn. Bhd. · Aug 1999
LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)
K991778 · Seltom Pacific Sdn. Bhd. · Aug 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE
K992165 · Pamitex Industries Sdn Bhd · 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
LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN)
K992031 · Shanghai Changzheng Latex Factory · Jul 1999