Cleared Traditional

K970773 - POWDER-FREE EXAM GLOVES

K970773 is an FDA 510(k) clearance for POWDER-FREE EXAM GLOVES, manufactured by Pt. Sarana Indoprotex. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K970773 · Pt. Sarana Indoprotex · General Hospital
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Dec 1997
Decision
275d
Days
Class 1
Risk

K970773 is an FDA 510(k) clearance for the POWDER-FREE EXAM GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Sarana Indoprotex (Lampung 35001, ID). The FDA issued a Cleared decision on December 4, 1997 after a review of 275 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 Pt. Sarana Indoprotex devices

FDA 510(k) Submission Details - K970773

510(k) Number K970773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1997
Decision Date December 04, 1997
Days to Decision 275 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
146d slower than avg
Panel avg: 129d · This submission: 275d
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 441
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K970773.
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED
K974518 · Yty Industry (Manjung) Sdn Bhd · Dec 1997
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
K973778 · Hartalega Sdn Bhd · Dec 1997
LOW POWDER POLYMER LATEX EXAMINATION GLOVES (WITH PROTEIN LABELING CLAIM)
K973871 · Hartalega Sdn Bhd · Dec 1997
HIGH RISK POWDERFREE LATEX EXAMINATION GLOVES (BLUE COLOUR)
K973801 · Sri Johani Sdn. Bhd. · Nov 1997
HIGH RISK POWDERED LATEX EXAMINATION GLOVES (BLUE COLOUR)
K973815 · Sri Johani Sdn. Bhd. · Nov 1997
Hi Coat Powder Free Latex Patient Examination Gloves
K972539 · P.T. Latexindo Tobaperkasa · Nov 1997