Cleared Traditional

K991511 - POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)

K991511 is an FDA 510(k) clearance for POWDERED NITRILE EXAMINATION GLOVE, manufactured by Perusahaan Getah Asas Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K991511 · Perusahaan Getah Asas Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
34d
Days
Class 1
Risk

K991511 is an FDA 510(k) clearance for the POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Perusahaan Getah Asas Sdn. Bhd. (Selangor, Darul Ehsan, MY). The FDA issued a Cleared decision on June 3, 1999 after a review of 34 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 Perusahaan Getah Asas Sdn. Bhd. devices

FDA 510(k) Submission Details - K991511

510(k) Number K991511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1999
Decision Date June 03, 1999
Days to Decision 34 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
95d faster than avg
Panel avg: 129d · This submission: 34d
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 1056
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K991511.
SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT
K991744 · Shield Gloves Manufacturer (M) Sdn Bhd · Jun 1999
SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES
K990186 · Shanghai Intco. Plastic & Rubber Products Co., Ltd. · Jun 1999
POWDER FREE BLUE NITRILE GLOVE
K990668 · Tg Medical Sdn. Bhd. · Jun 1999
HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES
K991640 · M.R.G. Industries Berhad · May 1999
RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)
K990963 · Riverstone Resources Sdn Bhd · May 1999
BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K991493 · Masju Sdn. Bhd. · May 1999