Cleared Traditional

K992686 - DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR

K992686 is an FDA 510(k) clearance for DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, manufactured by Sheen More Ent. Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K992686 · Sheen More Ent. Co., Ltd. · General Hospital
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Sep 1999
Decision
45d
Days
Class 1
Risk

K992686 is an FDA 510(k) clearance for the DISPOSABLE POWDER FREE NITRILE EXAM GLOVE, BLUE COLOR. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Sheen More Ent. Co., Ltd. (Tou-Liu, Yun-Lin, TW). The FDA issued a Cleared decision on September 24, 1999 after a review of 45 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 Sheen More Ent. Co., Ltd. devices

FDA 510(k) Submission Details - K992686

510(k) Number K992686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1999
Decision Date September 24, 1999
Days to Decision 45 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
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 975
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K992686.
TG MEDICAL POWDERED NITRILE EXAMINATION GLOVES
K992360 · Tg Medical Sdn. Bhd. · Oct 1999
NITRILE PATIENT EXAMINATION GLOVES, POWDERED, NON-STERILE
K992558 · Riverstone Resources Sdn Bhd · Sep 1999
QTEXX PRE-POWDERED NITRILE EXAMINATION GLOVES
K992671 · Latexx Partners Bhd. · Sep 1999
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
K992210 · Safeskin Corp. · Sep 1999
BLUE NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
K992588 · Formosa Glove Industrial Co., Ltd. · Sep 1999
N-DEX BLUE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE
K992170 · Best Manufacturing Company · Sep 1999