Cleared Traditional

K991821 - NITRILE EXAMINATION GLOVE, POWDERED, BLUE

K991821 is an FDA 510(k) clearance for NITRILE EXAMINATION GLOVE, manufactured by Ning BO Yujiang Rubber & Plastic Co.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K991821 · Ning BO Yujiang Rubber & Plastic Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
35d
Days
Class 1
Risk

K991821 is an FDA 510(k) clearance for the NITRILE EXAMINATION GLOVE, POWDERED, BLUE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ning BO Yujiang Rubber & Plastic Co. (Sparks, US). The FDA issued a Cleared decision on July 1, 1999 after a review of 35 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 Ning BO Yujiang Rubber & Plastic Co. devices

FDA 510(k) Submission Details - K991821

510(k) Number K991821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1999
Decision Date July 01, 1999
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 910
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K991821.
NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR
K991981 · Alliance Rubber Products Sdn. Bhd. · Aug 1999
POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE
K991615 · Maxxim Medical · Jul 1999
NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE
K992177 · Pt. Berlian Glovindo · Jul 1999
BRIGHTWAY BRAND BLUE NITRILE EXAMINATION GLOVES (POWDERED)
K990876 · Brightway Holdings Sdn. Bhd. · Jun 1999
HEALTH + AID PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K991304 · M.R.G. Industries Sdn. Bhd. · Jun 1999
SMART SHIELD NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES WITH BUBBLEGUM SCENT
K991744 · Shield Gloves Manufacturer (M) Sdn Bhd · Jun 1999