Cleared Traditional

K991777 - LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL EXTRACTABLE PROTEIN)

K991777 is an FDA 510(k) clearance for LATEX EXAMINATION GLOVES POWDER-FREE WI..., manufactured by Seltom Pacific Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K991777 · Seltom Pacific Sdn. Bhd. · General Hospital
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Aug 1999
Decision
98d
Days
Class 1
Risk

K991777 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVES POWDER-FREE WITH PROTEIN LABELING CLAIM (50 MICROGRA.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Seltom Pacific Sdn. Bhd. (Petaling Jaya, Selangor, MY). The FDA issued a Cleared decision on August 31, 1999 after a review of 98 days - within the typical 510(k) review window.

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.

View all Seltom Pacific Sdn. Bhd. devices

FDA 510(k) Submission Details - K991777

510(k) Number K991777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1999
Decision Date August 31, 1999
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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 612
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K991777.
ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR
K992419 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1999
CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)
K992358 · Biopro (M) Sdn Bhd · Sep 1999
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS)
K991969 · Pamitex Industries Sdn Bhd · Sep 1999
LATEX EXAMINATION GLOVES POLYMER COATED (POWDER-FREE)
K991778 · Seltom Pacific Sdn. Bhd. · Aug 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE
K992165 · Pamitex Industries Sdn Bhd · Aug 1999
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE
K992200 · Shen Wei (Usa), Inc. · Aug 1999