Cleared Traditional

K993912 - AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK), WITH PROTEIN CONTENT LABELING CLAIM (50 MI

K993912 is an FDA 510(k) clearance for AMBIDERM POWDER FREE LATEX EXAMINATION ..., manufactured by Latexx Partners, Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K993912 · Latexx Partners, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
84d
Days
Class 1
Risk

K993912 is an FDA 510(k) clearance for the AMBIDERM POWDER FREE LATEX EXAMINATION GLOVES (VIOLET, BLUE, GREEN AND PINK),.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Latexx Partners, Inc. (Crofton, US). The FDA issued a Cleared decision on February 9, 2000 after a review of 84 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 Latexx Partners, Inc. devices

FDA 510(k) Submission Details - K993912

510(k) Number K993912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1999
Decision Date February 09, 2000
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 K993912.
ROYAL SHIELD NON-STERILE PURPLE (PINK/BLUE) COLORED POWDERED LATEX EXAM WITH PROTEIN LABELING CLAIM [<200 MCG OR LESS] W
K000217 · Shield Gloves Manufacturer (M) Sdn Bhd · Feb 2000
HWA & SILKTEX POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (140 MICROGRAMS OR LESS)
K994432 · Hwa Teh Industrial Sdn. Bhd. · Feb 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION
K993918 · Pamitex Industries Sdn Bhd · Feb 2000
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS)
K994162 · Allegiance Healthcare Corp. · Feb 2000
AMBIDERM POWDERFREE LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM OF 50 MICROGRAMS OR LESS PER GRAM (BLACK COLORED)
K994131 · Medtaxx Partners · Feb 2000
RUBBERCARE POWDER-FREE, GUARDIAN POWDER-FREE LATEX EXAM GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K994201 · Perusahaan Pelindung Getah (M) Sdn Bhd · Feb 2000