Cleared Traditional

K000838 - DIGITCARE POWDER FREE COATED EXAMINATIO...

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
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 294
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K000838.
STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
K003653 · Wrp Asia Pacific Sdn. Bhd. · Jan 2001
NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
K003545 · Terang Nusa Sdn Bhd · Dec 2000
NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)
K003547 · Terang Nusa Sdn Bhd · Dec 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
LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM
K002314 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2000
NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
K002175 · Sgmp Co., Ltd. · Jul 2000