Cleared Abbreviated

K160781 - Sempermed Syntegra IR

K160781 is an FDA 510(k) clearance for Sempermed Syntegra IR, manufactured by Semperit Investments Asia Pte , Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Abbreviated 510(k) pathway after a 406-day FDA review.

K160781 · Semperit Investments Asia Pte , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2017
Decision
406d
Days
Class 1
Risk

K160781 is an FDA 510(k) clearance for the Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Semperit Investments Asia Pte , Ltd. (Singapore, SG). The FDA issued a Cleared decision on May 2, 2017 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Semperit Investments Asia Pte , Ltd. devices

FDA 510(k) Submission Details - K160781

510(k) Number K160781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2016
Decision Date May 02, 2017
Days to Decision 406 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
277d slower than avg
Panel avg: 129d · This submission: 406d
Pathway characteristics
Standards-based clearance path.

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 261
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K160781.
Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein
K172942 · Beta Healthcare Products Pvt., Ltd. · Jan 2018
Cardinal Health Sterile Polyisoprene Blend Powder-Free Surgical Gloves, Tested for Use with Chemotherapy Drugs (White)
K170198 · Cardinal Health, Inc. · Jun 2017
POLYCHLOROPRENE POWDER FREE SURGICAL GLOVE (GREEN)
K170152 · Hartalega Sdn Bhd · May 2017
Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs
K161823 · Wrp Asia Pacific Sdn. Bhd. · Jan 2017
Gammex Cut-Resistant Glove Liner
K160974 · Ansell Healthcare Products, LLC · Oct 2016
POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
K161008 · Hartalega Sdn Bhd · Jul 2016