Cleared Traditional

K961521 - PATIENT EXAMINATION GLOVE

K961521 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVE, manufactured by Shanghai PT Plastics Enterprise Company, Ltd.. The device is a Class 1 General Hospital device with product code LYZ cleared through the Traditional 510(k) pathway after a 283-day FDA review.

K961521 · Shanghai PT Plastics Enterprise Company, Ltd. · General Hospital
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Jan 1997
Decision
283d
Days
Class 1
Risk

K961521 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVE. Classified as Vinyl Patient Examination Glove (product code LYZ), Class I - General Controls.

Submitted by Shanghai PT Plastics Enterprise Company, Ltd. (Songjiang County Shanghai, CN). The FDA issued a Cleared decision on January 30, 1997 after a review of 283 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.

FDA 510(k) Submission Details - K961521

510(k) Number K961521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date January 30, 1997
Days to Decision 283 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
154d slower than avg
Panel avg: 129d · This submission: 283d
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 798
Devices cleared under the same product code (LYZ) and FDA review panel - the closest regulatory comparables to K961521.
JIAWANG PRE-POWDERED VINYL EXAMINATION GLOVES
K964800 · Shanghai Jiawang Industrial Co. , Ltd. · Feb 1997
VINYL PATIENT EXAMINATION GLOVES
K964629 · Arista Medi Prima · Feb 1997
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K964964 · Sunmax Enterprise Shanghai Co. , Ltd. · Feb 1997
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
K961521 · PATIENT EXAMINATION GLOVE
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