Cleared Traditional

K991779 - NITRILE EXAMINATION GLOVES POWDER FREE (BLUE)

K991779 is an FDA 510(k) clearance for NITRILE EXAMINATION GLOVES POWDER FREE ..., manufactured by Seltom Pacific Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K991779 · Seltom Pacific Sdn. Bhd. · General Hospital
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Aug 1999
Decision
78d
Days
Class 1
Risk

K991779 is an FDA 510(k) clearance for the NITRILE EXAMINATION GLOVES POWDER FREE (BLUE). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Seltom Pacific Sdn. Bhd. (Petaling Jaya, Selangor, MY). The FDA issued a Cleared decision on August 11, 1999 after a review of 78 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 Seltom Pacific Sdn. Bhd. devices

FDA 510(k) Submission Details - K991779

510(k) Number K991779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1999
Decision Date August 11, 1999
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 952
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K991779.
POWDERED NITRILE EXAMINATION GLOVE, BLUE OR WHITE (NON-COLORED)
K992497 · Kossan Latex Industries(M)Sdn Bhd · Aug 1999
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED NITRILE EXAMINATION GLOVE
K992299 · Pamitex Industries Sdn Bhd · Aug 1999
NITRILE EXAMINATION GLOVES POWDER FREE (WHITE)
K991776 · Seltom Pacific Sdn. Bhd. · Aug 1999
LAGLOVE BRAND BLUE COLOLRED NITRILE EXAMINATION GLOVE (POWDERED)
K990883 · La Glove (M) Sdn. Bhd. · Aug 1999
PATIENT EXAMINATION GLOVES, NITRILE POWDER FREE, TURQUOISE,NON-STERILE.
K991845 · Omnigrace , Ltd. · Aug 1999
PATIENT EXAMINATION GLOVE, NITRILE, POWDERED, TURQUOISE, NON-STERILE
K991846 · Omnigrace , Ltd. · Aug 1999