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) → HMT — Drape, Patient, Ophthalmic

# HMT · Drape, Patient, Ophthalmic

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

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

## Overview

- **Product Code:** HMT
- **Device Name:** Drape, Patient, Ophthalmic
- **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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K945738](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMT/K945738.md) | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE | Visitec Co. | Feb 14, 1995 | SESE |
| [K905460](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMT/K905460.md) | STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY | Angiosystems, Inc. | Feb 6, 1991 | SESE |
| [K872620](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMT/K872620.md) | SOLOS EYESITE DRAPES | Solos Ophthalmology | Jul 31, 1987 | SESE |
| [K871706](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMT/K871706.md) | OPTHA PREP | Treace Medical, Inc. | May 18, 1987 | SESE |
| [K854613](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMT/K854613.md) | SURGICAL DRAPES, OPHTHALMIN | Charles Atkins & Co. | Feb 13, 1986 | SESE |
| [K831340](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMT/K831340.md) | DRAIN-R-DRAPE(EYE | Sur-Tech, Inc. | Jun 8, 1983 | SESE |
| [K830822](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/HMT/K830822.md) | EYE DRAPE | CooperVision, Inc. | Apr 6, 1983 | SESE |

## Top Applicants

- Angiosystems, Inc. — 1 clearance
- Charles Atkins & Co. — 1 clearance
- CooperVision, Inc. — 1 clearance
- Solos Ophthalmology — 1 clearance
- Sur-Tech, Inc. — 1 clearance

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

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