Cleared Traditional

K992860 - DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR

K992860 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE VINYL SYNTHETIC ..., manufactured by Shijiazhuang Hongray Plastic Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K992860 · Shijiazhuang Hongray Plastic Products Co., Ltd. · General Hospital
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Sep 1999
Decision
30d
Days
Class 1
Risk

K992860 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shijiazhuang Hongray Plastic Products Co., Ltd. (Hebei Province, CN). The FDA issued a Cleared decision on September 24, 1999 after a review of 30 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 Shijiazhuang Hongray Plastic Products Co., Ltd. devices

FDA 510(k) Submission Details - K992860

510(k) Number K992860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1999
Decision Date September 24, 1999
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

LYZ Device Classification - Class 1, General Controls

Product Code LYZ Vinyl Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) 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 - LYZ Vinyl Patient Examination Glove

All 205
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K992860.
SENSI-PRO, DISPOSABLE POWDERED VINYL SYNTHETIC EXAMINATION GLOVES, WHITE COLOR
K992922 · Shijiazhuang Hongray Plastic Products Co., Ltd. · Oct 1999
PRE-POWDERED VINYL PATIENT EXAMINATION GLOVES
K992271 · Shanghai Cosmos Corp. · Oct 1999
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992272 · Shanghai Cosmos Corp. · Oct 1999
SYNTHETIC POWDERED VINYL PATIENT EXAMINATION GLOVES
K992464 · Shijiazhuang Dilly Plastics Products Co., Ltd. · Sep 1999
SYNTHETIC POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K992463 · Shijiazhuang Dilly Plastics Products Co., Ltd. · Aug 1999
BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES
K992107 · General Gloves Corp. · Aug 1999