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K Number
K992005
Device Name
GILTECH PLUS TRANSPARENT DRESSING
Manufacturer
GILTECH PLUS, INC.
Date Cleared
1999-09-03

(80 days)

Product Code
MGP
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Giltech Plus Transparent Dressing is indicated for the management of moderately draining wounds such as:

(a) Stage I and II pressure sores (decubitus ulcers)

(b) Skin tears or lacerations

(c) Superficial burns and abrasions

(d) Surgical wounds

Device Description

Transparent Dressing

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Giltech Plus Transparent Dressing." This document addresses the substantial equivalence of the device and its indications for use, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information based on the input text. The document is strictly a regulatory clearance and does not delve into the technical details of device validation.

N/A