Cleared Traditional

K000838 - DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K000838 is an FDA 510(k) clearance for DIGITCARE POWDER FREE COATED EXAMINATIO..., manufactured by P.T. Healthcare Glovindo. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K000838 · P.T. Healthcare Glovindo · General Hospital
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Oct 2000
Decision
223d
Days
Class 1
Risk

K000838 is an FDA 510(k) clearance for the DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by P.T. Healthcare Glovindo (Medan, ID). The FDA issued a Cleared decision on October 23, 2000 after a review of 223 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 P.T. Healthcare Glovindo devices

FDA 510(k) Submission Details - K000838

510(k) Number K000838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2000
Decision Date October 23, 2000
Days to Decision 223 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
94d slower than avg
Panel avg: 129d · This submission: 223d
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 817
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K000838.
DERMAGRIP POWDER FREE BLUE POLYMER COATED LATEX EXAMINATION GLOVE, NON-STERILE CONTAINS 50 MICROGRAM OR LESS OF TOTAL WA
K003132 · Wrp Specialty Products Sdn. Bhd. · Nov 2000
FORMULA ONE STERILE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (200 MICROGRAMS OR LESS) MADE FROM ALLO
K002720 · Tillotson Healthcare Corp. · Nov 2000
DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL
K002975 · Wrp Specialty Products Sdn. Bhd. · Oct 2000
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (200 MICROGRAMS OR LESS)
K002922 · Omnigrace (Thailand) , Ltd. · Oct 2000
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K002568 · Smart Glove Corp. Sdn Bhd · Oct 2000
POWDER FREE LATEX EXAMINATION PATIENT GLOVES
K994420 · Purna Bina Sdn Bhd · Sep 2000