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General product information from regulator records and the manufacturer’s printed instructions, checked 2026-10-30. It is not medical advice and not a procedure guide; a clinician decides whether and how a closure device is used.
Short answer
Clozex is a single-use, adhesive-pad skin closure device from Clozex Medical, Inc. that holds the edges of a skin incision or laceration together with filament straps instead of sutures. In FDA’s records it is product code MZR under 21 CFR 880.5240, a Class I device exempt from premarket notification. Zip is a different brand of the same general kind, with its own FDA record (Zip 4, K170003).
Definition and scope
The manufacturer’s patient instructions describe Clozex as made of polymeric (plastic) components coated with a pressure sensitive skin adhesive. The application sheet names its parts: adhesive pads, filament straps, pulling tabs, tab perforations and liners. The company’s site presents it as a closure for surgical incisions and traumatic lacerations, with separate pages for medical professionals and for personal use.
“Zip surgical skin closure” refers to a comparable adhesive-based closure device. This page covers only what FDA’s public record states about the Zip 4 device; it does not describe how Zip works.
A skin closure device is not a suture, a staple or a tissue adhesive. See the CASRAI guides on surgical stapler types, Dermabond and Prineo skin adhesives, butterfly closures and Steri-Strip for those neighbouring product types.
What the label says about wear time
The Clozex patient instructions (document DWG-0088-02) state that the device is made to stay in place from 7 to 10 days and then naturally slough (fall) off the skin. The same document says wear and hold time vary with patient care, skin location and skin type. Application and removal are covered only by the instructions for use that ship with the product, which are written for the wearer and the treating clinician.
Clozex and Zip: the regulatory identity
Both brands sit under the same regulation text, but their FDA records look different.
| Item | Clozex | Zip 4 Skin Closure Device |
|---|---|---|
| Company in FDA record | Clozex Medical, Inc. | Zipline Medical, Inc. |
| FDA product code | MZR, “Topical Approximation System” | PYO, adhesive tape and bandage with adjustable closing mechanism, OTC use |
| Regulation | 21 CFR 880.5240 | 21 CFR 880.5240 |
| Device class | Class I | Class I |
| Premarket record | No 510(k) number in the FDA records checked; Class I devices under this regulation are exempt from premarket notification | 510(k) K170003, Substantially Equivalent, decision date 2017-08-18 (received 2017-01-03) |
| GUDID term | GMDN 32207, “Skin-closure adhesive strip”, single-use | Not stated in the record checked |
The regulation, 21 CFR 880.5240, covers medical adhesive tape and adhesive bandages intended to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin. Paragraph (b) classifies the device as Class I (general controls) and exempts it from the premarket notification procedures in subpart E of part 807, subject to the limitations in 21 CFR 880.9.
Clozex pack sizes and labelling channels
FDA’s device identifier data (openFDA, drawn from the GUDID database) lists 18 Clozex-branded records, all single-use and all shown as in commercial distribution at the time of checking. They fall into two labelling channels: prescription (Rx) and over-the-counter (OTC).
| Channel | Description in record | Lengths listed |
|---|---|---|
| Rx | “Clozex Closures”, box of 10 closure devices | 15, 20, 25, 30, 40 (small strap), 40 (large strap), 50, 60, 80 and 100 mm |
| OTC | “Laceration Closures”, single sizes | 25 and 40 mm |
| OTC | Assorted closure packs | 20/30/40 mm and 20/40/50 mm |
| OTC | Pediatric assorted closures | 15/20/25 mm |
| OTC | Laceration kits with accessories (product code OHO, first aid kit without drug) | 40 mm; 50 mm; 40 and 25 mm |
The length in millimetres is the part of the description that distinguishes one closure SKU from another, and “box of 10” is the pack quantity stated for the Rx listings.
Where it matters for clinic and supply lists
- Reading a listing. A catalogue line for a Clozex closure carries a length in mm, a pack count and a channel (Rx or OTC). The 40 mm Rx listing is split by strap size (small or large), so two entries share one length.
- Kits are a different product code. The OTC laceration kits are registered under OHO, not MZR, because they bundle accessories with the closures.
- Single-use. Every Clozex record is flagged single-use, so a supply list counts devices as consumed items.
- Related kit content. For the wider category of wound-care kits, see the CASRAI guide on wound closure kit contents.
Common misunderstandings
Is Clozex “FDA approved”?
The FDA records checked show no approval. Under 21 CFR 880.5240 the device is Class I and exempt from premarket notification, which is a different regulatory status from a 510(k) clearance such as the one Zip 4 holds.
Is a skin closure device the same as a suture or skin glue?
No. Clozex uses adhesive pads joined by filament straps; sutures, staples and liquid tissue adhesives are separate product types with their own regulation and labelling.
Are Clozex and Zip the same product?
No. They are different brands from different companies with separate FDA records, though both fall under the same regulation.
FAQ
What is Clozex used for?
According to the manufacturer, it closes surgical incisions and traumatic lacerations by holding the skin edges together. Whether it suits a particular wound is a clinician’s decision.
How long does a Clozex stay on?
The patient instructions say it is made to stay in place from 7 to 10 days and then fall off naturally, with wear time varying by care, skin location and skin type.
What does “zip surgical skin closure” refer to?
It refers to Zip-brand closure devices from Zipline Medical. FDA’s record for Zip 4 is 510(k) K170003, decided 2017-08-18 as substantially equivalent.
What FDA class is Clozex?
Class I, product code MZR, regulation 21 CFR 880.5240.
Sources
All sources checked on 2026-10-30.
- Clozex Medical, Inc., Patient Instructions DWG-0088-02: https://cdn.shopify.com/s/files/1/0052/1155/3881/files/DWG-0088_Patient_Instructions_NO_CLM.pdf
- Clozex Medical, Inc., Step-By-Step Application DWG-0086-02 (component names): https://cdn.shopify.com/s/files/1/0052/1155/3881/files/DWG-0086_Application_Instructions_NO_CLM.pdf
- Clozex Medical, Inc. product site: https://www.clozex.com
- FDA openFDA device UDI endpoint (GUDID data), brand name Clozex: https://api.fda.gov/device/udi.json?search=brand_name:clozex
- FDA openFDA 510(k) record K170003, Zip 4 Skin Closure Device: https://api.fda.gov/device/510k.json?search=k_number:K170003
- 21 CFR 880.5240, Medical adhesive tape and adhesive bandage: https://www.ecfr.gov/current/title-21/section-880.5240
