Cleared Traditional

K981975 - LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED

K981975 is an FDA 510(k) clearance for LATEX PATIENT EXAMINATION GLOVE POWDERF..., manufactured by Siam Sempermed Corp., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K981975 · Siam Sempermed Corp., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
168d
Days
Class 1
Risk

K981975 is an FDA 510(k) clearance for the LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Siam Sempermed Corp., Ltd. (Palm Harbor, US). The FDA issued a Cleared decision on November 20, 1998 after a review of 168 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 - K981975

510(k) Number K981975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1998
Decision Date November 20, 1998
Days to Decision 168 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
39d slower than avg
Panel avg: 129d · This submission: 168d
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 1238
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K981975.
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM
K982716 · Omnigrace (Thailand) , Ltd. · Nov 1998
MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE
K982877 · Matang Mfg. Sdn. Bhd. · Nov 1998
SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX EXMINATION GLOVE
K982416 · Shun Thai Rubber Gloves Industry Co., Ltd. · Nov 1998
EVERGREEN NON-STERILE, POWDER-FREE, PROTEIN CONTENT LABELING CLAIM EXAMINATION GLOVES: NATURAL, BLUE & PINK
K983608 · Yty Industry (Manjung) Sdn Bhd · Nov 1998
LATEX EXAMINATION GLOVES BUBBLE GUM FLAVOURED PRE-POWDERED
K981600 · Young Innovations, LLC Dba Plak Smacker · Nov 1998
UNIJECT LATEX EXAMINATION GLOVES (POWDER FREE)
K982611 · Uniject Gloves Pcl · Nov 1998
K981975 · LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
Download PDF FDA Summary Siam Sempermed Corp.,…