Who is the manufacturer of DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)?

Richard Hamer Assoc., Inc. filed the 510(k) submission for DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10) (K962439).

What is the FDA product code for DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)?

MGQ. as a Class U device in the SU panel.

What is the regulatory pathway for DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)

K962439 · Richard Hamer Assoc., Inc. · MGQ · Sep 3, 1996 · SU

Device Facts

Record ID	K962439
Device Name	DERMAPLEX HYDROGEL WOUND DRESSING (2X2,4X4,4X8,6X10)
Applicant	Richard Hamer Assoc., Inc.
Product Code	MGQ · SU
Decision Date	Sep 3, 1996
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.

Device Story

Dermaplex Hydrogel Wound Dressing; 12-ply cotton gauze pad impregnated with clear, viscous hydrogel; supplied sterile in sealed aluminum/plastic laminate pouches. Used for local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full/partial thickness wounds. Applied topically to wound site by clinician or patient to provide moist wound environment. Benefits include wound protection and management of exudate.

Clinical Evidence

No clinical data. Biocompatibility established via bench testing: primary dermal irritation (rabbits), sensitization (guinea pigs), and USP Cytotoxicity (Agarose Diffusion).

Technological Characteristics

12-ply cotton gauze pad impregnated with hydrogel. Available in four sizes: 2"x2", 4"x4", 4"x8", 6"x10". Supplied sterile in aluminum/plastic laminate pouches. Biocompatibility per USP Cytotoxicity (Agarose Diffusion).

Indications for Use

Indicated for patients requiring local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.

Predicate Devices

MPM GelPad (K933495)

Related Devices

K993119 — STERILE HYDROGEL · Dumex Medical Surgical Products, Ltd. · Nov 23, 1999
K973693 — AQUA PATCH · Pci Technology · Dec 18, 1997
K972336 — DERMAMEND HYDROGEL GAUZE DRESSING · Dermarx Corp. · Jul 29, 1997
K983362 — NU-GEL * WOUND DRESSING · Johnson & Johnson Medical, Inc. · Dec 16, 1998
K965005 — IAMIN IMPREGNATED GAUZE DRESSING · Procyte Corp. · Feb 24, 1997

Submission Summary (Full Text)

{0} K962439 SEP 3 1996 510 (k) SUMMARY I. ADMINISTRATIVE Submitter: Maxxim Medical, Inc. 104 Industrial Boulevard Sugar Land, Texas 77478 713-240-2442 Contact Person: Ernest J. Henley Date of Preparation: July 3, 1996 II. DEVICE NAME Proprietary Name: Dermaplex Hydrogel Wound Dressing Common Name: Wound Dressing Classification Name: Hydrogel wound and burn dressing III. PREDICATE DEVICE MPM GelPad (Hydrogel Saturated Sterile Gauze); MPM Medical, Inc.; K933495. IV. DEVICE DESCRIPTION The Dermaplex Hydrogel Wound Dressing consists of a 12-ply cotton gauze pad dressing impregnated with a clear, viscous hydrogel. The product is available in four sizes (2" x 2", 4" x 4", 4" x 8" and 6" x 10") and is supplied sterile in sealed aluminum/plastic laminate pouches. Biocompatibility of the device has been established by a primary dermal irritation test in rabbits and a sensitization test in guinea pigs. The product meets the requirements of the USP Cytotoxicity Test (Agarose Diffusion). V. INTENDED USE For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds. {1} K962439 ## VI. COMPARISON TO PREDICATE DEVICE The Dermaplex Hydrogel Wound Dressing is similar in composition, function and intended use to the MPM GelPad (MPM Medical, Inc., K933495) and other wound dressing products consisting of a cotton pad saturated with hydrogel. Accordingly, Maxxim Medical, Inc. concluded that the Dermaplex Hydrogel Wound Dressing is as safe and effective for its intended use and performs at least as well as legally marketed predicate devices, such as the MPM GelPad. Premarket Notification K962439