Cleared Traditional

K963797 - PM SYNTHETIC MEDICAL GLOVES, POWDER FREE

K963797 is an FDA 510(k) clearance for PM SYNTHETIC MEDICAL GLOVES, manufactured by Shanghai PM Plastics Enterise Co., Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K963797 · Shanghai PM Plastics Enterise Co., Ltd. · General Hospital
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Oct 1996
Decision
36d
Days
Class 1
Risk

K963797 is an FDA 510(k) clearance for the PM SYNTHETIC MEDICAL GLOVES, POWDER FREE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai PM Plastics Enterise Co., Ltd. (Shongjiang County, Shanghai, CN). The FDA issued a Cleared decision on October 29, 1996 after a review of 36 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 PM Plastics Enterise Co., Ltd. devices

FDA 510(k) Submission Details - K963797

510(k) Number K963797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1996
Decision Date October 29, 1996
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 317
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K963797.
GLOVE, PATIENT EXAMINATION, VINYL (POWDERED)
K964321 · Shijiazhuang Hongray Plastic Products Co., Ltd. · Jan 1997
POWDER FREE VINYL EXAMINATION GLOVE
K964545 · Shanghai Poseidon Plastic Products Co., Ltd. · Dec 1996
PT SYNTHETIC MEDICAL GLOVES, POWDER FREE
K963751 · Shanghai PT Plastics Enterprise Company, Ltd. · Oct 1996
PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED)
K963514 · Shanghai PM Plastics Enterise Co., Ltd. · Oct 1996
PACER PLUS SYNTHETIC MEDICAL VINYL PATIENT EXAMINATION GLOVE POWDER FREE
K963710 · Canopus Medical Supply Co., Ltd. · Oct 1996
PREPOWDER VINYL PATIENT EXAMINATION GLOVES
K962026 · Hong Huang Tang Industrial Co., Ltd. · Sep 1996