Cleared Traditional

K991849 - NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER EXTRAC

K991849 is an FDA 510(k) clearance for NON-STERILE POWDER-FREE LATEX EXAMINATI..., manufactured by Seal Polymer Industries Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K991849 · Seal Polymer Industries Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
36d
Days
Class 1
Risk

K991849 is an FDA 510(k) clearance for the NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Seal Polymer Industries Bhd. (Lahat, Ipoh, Perak, MY). The FDA issued a Cleared decision on July 7, 1999 after a review of 36 days - a notably fast clearance 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: 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 Seal Polymer Industries Bhd. devices

FDA 510(k) Submission Details - K991849

510(k) Number K991849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1999
Decision Date July 07, 1999
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K991849.
LATEX EXAMINATION GLOVE POWDER FREE, WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS TOTAL WATER SOLUBLE PROTEIN)
K992031 · Shanghai Changzheng Latex Factory · Jul 1999
GLOVCO, POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K991554 · Glovco (M) Sdn. Bhd. · Jul 1999
POLYMER COAT,POWDER FREE, LATEX EXAMINATION GLOVES
K991624 · Smart Glove Corp. Sdn Bhd · Jul 1999
LATEX EXAMINATION GLOVES (POWDER FREE)
K991689 · Usg Healthguard Sdn Bhd · Jun 1999
LATEX EXAMINATION GLOVES (PRE POWDERED)
K991690 · Usg Healthguard Sdn Bhd · Jun 1999
ROYAL SHIELD NON-STERILE BUBBLE GUM SCENTED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (5O
K991743 · Shield Gloves Manufacturer (M) Sdn Bhd · Jun 1999