Cleared Traditional

K201774 - Polychloroprene Powder Free Sterile Sur...

K201774 is the FDA 510(k) clearance for Polychloroprene Powder Free Sterile Sur... by Pt. Medisafe Technologies. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K201774 · Pt. Medisafe Technologies · General Hospital
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Sep 2020
Decision
79d
Days
Class 1
Risk

K201774 is an FDA 510(k) clearance for the Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Pt. Medisafe Technologies (Tanjung Morawa, Medan, ID). The FDA issued a Cleared decision on September 16, 2020 after a review of 79 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 Pt. Medisafe Technologies devices

Submission Details

510(k) Number K201774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2020
Decision Date September 16, 2020
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 143
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K201774.
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
K202090 · Molnlycke Health Care Us, LLC · Nov 2020
Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein
K202449 · Medline Industries, Inc. · Nov 2020
Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs
K201748 · Hartalega Sdn Bhd · Oct 2020
SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
K201829 · Medline Industries, Inc. · Sep 2020
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
K200897 · Hartalega Sdn Bhd · Jun 2020
Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro
K193573 · Molnlycke Health Care Us, LLC · Apr 2020