Cleared Traditional

K963514 - PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED)

K963514 is an FDA 510(k) clearance for PACER PLUS SYNTHETIC MEDICAL VINLY PATI..., 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 51-day FDA review.

K963514 · Shanghai PM Plastics Enterise Co., Ltd. · General Hospital
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Oct 1996
Decision
51d
Days
Class 1
Risk

K963514 is an FDA 510(k) clearance for the PACER PLUS SYNTHETIC MEDICAL VINLY PATIENT EXAMINATION GLOVES (POWDERED). Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai PM Plastics Enterise Co., Ltd. (Songjiang Co., Shanghai, CN). The FDA issued a Cleared decision on October 24, 1996 after a review of 51 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 - K963514

510(k) Number K963514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1996
Decision Date October 24, 1996
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
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 K963514.
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
PM SYNTHETIC MEDICAL GLOVES, POWDER FREE
K963797 · 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
MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES
K962069 · Medline Industries, Inc. · Aug 1996