← Product Code MGQ · K964620

# PANOGAUZE NON-WOVEN HYDROGEL DRESSING (K964620)

_Sage Pharmaceuticals, Inc. · MGQ · Jan 9, 1997 · SU · SN_

**Canonical URL:** https://fda.innolitics.com/device/K964620

## Device Facts

- **Applicant:** Sage Pharmaceuticals, Inc.
- **Product Code:** MGQ
- **Decision Date:** Jan 9, 1997
- **Decision:** SN
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** SU
- **Attributes:** Therapeutic

## Intended Use

PanoGauze™ Non-Woven Hydrogel Dressing is intended to provide a moist packing/healing environment which helps to prevent wound desiccation.

## Device Story

PanoGauze™ is a sterile, single-use, absorbent non-woven pad saturated with water-based hydrogel; packaged in poly/Mylar-laminate pouches. Used in clinical or home settings for wound and burn management. Provides moist environment to prevent wound desiccation. Healthcare provider applies dressing to wound bed; maintains moist environment to facilitate healing. Benefits include protection of wound bed and prevention of desiccation.

## Clinical Evidence

Bench testing only. Independent laboratory studies confirmed USP compliance for systemic toxicity and cytotoxicity. Testing per 16 CFR 1500 (FHSA) showed no primary skin irritation and no evidence of delayed dermal contact sensitization.

## Technological Characteristics

Non-woven absorbent pad saturated with water-based hydrogel. Sterile, single-use. Packaging: poly/Mylar-laminate pouches. Class II device (21 CFR 878.4022).

## Predicate Devices

- Carrington Laboratories, Inc. CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad ([K915001](/device/K915001.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

JAN - 9 1997
K964620

# Summary Basis of Substantial Equivalence.
510 (k) Summary

PanoGauze™ Non-Woven Hydrogel Dressing is substantially equivalent in design, composition and function to the Carrington Laboratories, Inc. CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad, 510(k) #K915001, authorized for marketing January 31, 1992.

This is a Class II, (21 CFR §878.4022) Hydrogel Wound & Burn Dressing. There are no established performance standards. PanoGauze™ Non-Woven Hydrogel Dressing, like the CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad, is intended to provide a moist packing/healing environment which helps to prevent wound desiccation. Both are absorbent pads saturated with water based hydrogels packaged in sterile single-use poly/Mylar-laminate pouches.

In regards to safety, several studies were conducted by an independent testing laboratory that demonstrate the following with regard to PanoGauze™ Non-Woven Hydrogel Dressing:

- Met the USP requirements for systemic toxicity,
- Meets USP requirements for cytotoxicity,
- Is not considered a primary irritant to the skin per the guidelines of the Federal Hazardous Substances Act (FHSA) Regulations, 16 CFR 1500. In fact, no irritation was observed,
- Showed no evidence of causing delayed dermal contact sensitization.

In summary, PanoGauze™ Non-Woven Hydrogel Dressing can be determined to be substantially equivalent to CarraGauze™ Carrasyn™ Gel Wound Dressing Saturated Pad on the basis that it maintains a moist environment in the wound bed, does not introduce microbial contamination, and is safe to use - as established by negative results when tested for toxicity.

510 (k) PREMARKET NOTIFICATION
Page 2

---

**Source:** [https://fda.innolitics.com/device/K964620](https://fda.innolitics.com/device/K964620)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com