Cleared Traditional

K990186 - SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES

K990186 is an FDA 510(k) clearance for SYNTHETIC POWDER-FREE NITRILE PATIENT E..., manufactured by Shanghai Intco. Plastic & Rubber Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K990186 · Shanghai Intco. Plastic & Rubber Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
152d
Days
Class 1
Risk

K990186 is an FDA 510(k) clearance for the SYNTHETIC POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Shanghai Intco. Plastic & Rubber Products Co., Ltd. (Chino, US). The FDA issued a Cleared decision on June 21, 1999 after a review of 152 days - an extended review 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: 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 Shanghai Intco. Plastic & Rubber Products Co., Ltd. devices

FDA 510(k) Submission Details - K990186

510(k) Number K990186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1999
Decision Date June 21, 1999
Days to Decision 152 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
23d slower than avg
Panel avg: 129d · This submission: 152d
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 1025
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K990186.
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
POWDER FREE BLUE NITRILE GLOVE
K990668 · Tg Medical Sdn. Bhd. · Jun 1999
POWDERED NITRILE EXAMINATION GLOVE, WHITE (NON-COLORED)
K991511 · Perusahaan Getah Asas Sdn. Bhd. · Jun 1999
HEALTH AID PREMIUM PRE-POWDERED NITRILE EXAMINATION GLOVES
K991640 · M.R.G. Industries Berhad · May 1999