Cleared Traditional

K070821 - POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE

K070821 is an FDA 510(k) clearance for POWDERED NATURAL RUBBER LATEX EXAMINATI..., manufactured by Medtexx Manufacturing Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K070821 · Medtexx Manufacturing Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
45d
Days
Class 1
Risk

K070821 is an FDA 510(k) clearance for the POWDERED NATURAL RUBBER LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) 200 MI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Medtexx Manufacturing Sdn. Bhd. (Kamunting, Taiping, Perak, MY). The FDA issued a Cleared decision on May 10, 2007 after a review of 45 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 Medtexx Manufacturing Sdn. Bhd. devices

FDA 510(k) Submission Details - K070821

510(k) Number K070821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2007
Decision Date May 10, 2007
Days to Decision 45 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 129d · This submission: 45d
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 403
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K070821.
NON-STERILE, POWDERED, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (200 UG OR LESS)
K072403 · Sgmp Co., Ltd. · Mar 2008
NON-STERILE, POWDER FREE, PINK LATEX EXAMINATION GLOVES WITH CHERRY FLAVOUR AND PROTEIN LABELING CLAIMS (50 UG OR LESS)
K072406 · Sgmp Co., Ltd. · Mar 2008
NON-STERILE, LATEX POWDER FREE PATIENT EXAMINATION GLOVES (MULTICOLORED WITH XYLITOL AND CALCIUM CARBONATE)
K071060 · Sgmp Co., Ltd. · Jul 2007
CHLORINATED, POLYMER-COATED POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM
K062965 · Kossan Latex Industries(M)Sdn Bhd · Dec 2006
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE,WITH EXTRACTABLE PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAM PER GRAM OF
K060775 · Kossan Latex Industries(M)Sdn Bhd · May 2006
BRIGHTWAY BRAND LATEX EXAMINATION GLOVES (POWDER FREE, BLACK COLOR)
K060658 · Brightway Holdings Sdn. Bhd. · Apr 2006