Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4370](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4370) → NZP — Sealant, Microbial

# NZP · Sealant, Microbial

_General, Plastic Surgery · 21 CFR 878.4370 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NZP

## Overview

- **Product Code:** NZP
- **Device Name:** Sealant, Microbial
- **Regulation:** [21 CFR 878.4370](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4370)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

## Classification Rationale

Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K223669](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NZP/K223669.md) | SecurePortIV Advanced Catheter Securement Adhesive | Adhezion Biomedical, LLC | Jun 12, 2023 | SESE |
| [K170505](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NZP/K170505.md) | SecurePortIV Catheter Securement Adhesive | Adhezion Biomedical, LLC | Sep 29, 2017 | SESE |
| [K083354](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NZP/K083354.md) | FLORASEAL, MODEL FS350D | Adhezion Biomedical | Jul 20, 2009 | SESE |
| [K052870](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NZP/K052870.md) | INTEGUSEAL MICROBIAL SEALANT, MODEL IS 100 AND 1S200 | Kimberly-Clark Corp. | Sep 29, 2006 | SESE |

## Top Applicants

- Adhezion Biomedical, LLC — 2 clearances
- Adhezion Biomedical — 1 clearance
- Kimberly-Clark Corp. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NZP](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NZP)

**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