Cleared Traditional

K952851 - SAFESKIN

K952851 is an FDA 510(k) clearance for SAFESKIN, manufactured by Safeskin Corp.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K952851 · Safeskin Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
51d
Days
Class 1
Risk

K952851 is an FDA 510(k) clearance for the SAFESKIN. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Safeskin Corp. (San Diego, US). The FDA issued a Cleared decision on August 11, 1995 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 Safeskin Corp. devices

FDA 510(k) Submission Details - K952851

510(k) Number K952851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1995
Decision Date August 11, 1995
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
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.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 264
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K952851.
HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE
K953379 · Ansell, Inc. · Sep 1995
LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER
K951018 · Siam Sempermed Corp., Ltd. · Aug 1995
SAFESKIN
K952793 · Safeskin Corp. · Aug 1995
HYPOALLERGENIC POWDERED AMBIDEXTROUS PATIENT EXAMINATION GLOVES
K945766 · Ansell, Inc. · Aug 1995
CYPRESS MEDICAL PRODUCTS VINYL EXAMINATION GLOVE
K952367 · Cypress Medical Products, Ltd. · Jul 1995
LATEX PATIENT EXAMINATION GLOVE POWDER FREE (HYPOALLERGENIC)
K946257 · Siam Sempermed Corp., Ltd. · Jun 1995