Cleared Traditional

K972090 - POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES

K972090 is an FDA 510(k) clearance for POWDER-FREE HYPOALLERGENIC NITRILE EXAM..., manufactured by Shen Wei (Usa), Inc.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K972090 · Shen Wei (Usa), Inc. · General Hospital
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Nov 1997
Decision
154d
Days
Class 1
Risk

K972090 is an FDA 510(k) clearance for the POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shen Wei (Usa), Inc. (Union City, US). The FDA issued a Cleared decision on November 5, 1997 after a review of 154 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.

View all Shen Wei (Usa), Inc. devices

FDA 510(k) Submission Details - K972090

510(k) Number K972090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1997
Decision Date November 05, 1997
Days to Decision 154 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
25d slower than avg
Panel avg: 129d · This submission: 154d
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 1019
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K972090.
PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE)
K973058 · Sri Johani Sdn. Bhd. · Nov 1997
PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K973059 · Sri Johani Sdn. Bhd. · Nov 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K973551 · Pwa Industries Sdn. Bhd. · Nov 1997
ROYAL SHIELD NON-STERILE POWDERFREE, COLORED NITRILE EXAMINATION GLOVE
K972757 · Shield Gloves Manufacturer (M) Sdn Bhd · Oct 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K972169 · Pwa Industries Sdn. Bhd. · Oct 1997
NITRILE EXAMINATION GLOVES-PRE POWDERED
K970216 · Influx Pacific Sdn. Bhd. · Sep 1997