Cleared Traditional

K991317 - POWDER-FREE LATEX SURGEON'S GLOVE SAFES...

K991317 is an FDA 510(k) clearance for POWDER-FREE LATEX SURGEON'S GLOVE SAFES..., manufactured by Safeskin Corp.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K991317 · Safeskin Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
32d
Days
Class 1
Risk

K991317 is an FDA 510(k) clearance for the POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS O.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Safeskin Corp. (San Diego, US). The FDA issued a Cleared decision on May 21, 1999 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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 - K991317

510(k) Number K991317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1999
Decision Date May 21, 1999
Days to Decision 32 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
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

KGO Device Classification - Class 1, General Controls

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, 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 - KGO Surgeon's Gloves

All 241
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K991317.
ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES
K991992 · Allegiance Healthcare Corp. · Jul 1999
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDERED)
K991940 · Brightway Holdings Sdn. Bhd. · Jul 1999
BRIGHTWAY BRAND NITRILE SURGICAL GLOVES - STERILE (POWDER-FREE)
K991939 · Brightway Holdings Sdn. Bhd. · Jul 1999
SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES
K983982 · Maxxim Medical · May 1999
PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
K982600 · Wembley Rubber Products (M) Sdn Bhd · Mar 1999
SENSIFLEX POWDERFREE SURGEON'S GLOVE
K982957 · Terang Nusa Sdn Bhd · Jan 1999