DISPOSABLE APRON

K964364 · Instrument Makar, Inc. · LYU · Feb 25, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964364
• Device Name: DISPOSABLE APRON
• Applicant: Instrument Makar, Inc.
• Product Code: LYU · General, Plastic Surgery
• Decision Date: Feb 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 1

Intended Use

The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healthcare worker from the transfer of micro-organisms, blood, body fluids and particulate material between the worker and the patient. The Disposable Apron is a disposable product intended for single use only.

Device Story

Disposable apron manufactured from 6 gauge embossed Poly-Vinyl; worn over clothing in hospital environments by healthcare personnel. Device design features one-size-fits-most form factor; secured by slipping over head and tying behind back. Provides physical barrier covering front of body to prevent cross-contamination of fluids and particulates. Single-use, non-sterile product.

Clinical Evidence

Bench testing only. Viral penetration testing performed using ASTM F1671-95 method with oX174 bacteriophage challenge suspension (1.0 x 10^8 PFU/mL). 32 samples tested; 100% pass rate with no viral penetration observed.

Technological Characteristics

Material: 6 gauge embossed Poly-Vinyl. Form factor: One-size-fits-most apron. Securing mechanism: Neck loop and back ties. Sterility: Non-sterile. Testing standard: ASTM F1671-95 for viral penetration.

Indications for Use

Indicated for hospital personnel to protect against transfer of micro-organisms, blood, body fluids, and particulate material between the worker and the patient.

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Predicate Devices

• Sloan Medical, Disposable Surgical Jumpsuit
• Associated Bag, Apron

Reference Devices

• Instrument Makar, Fluid Barrier Boots (K955835)

Submission Summary (Full Text)

{0}

FEB 25 1997
K964364

# 510(k) Summary of Safety and Effectiveness

Submitter: Instrument Makar, Inc
2950 E Mt. Hope Road
Okemos, MI 48864

Date of Summary: K964364
2/20/97

Phone: [phone]
Fax: [phone]
Contact: Autumn Johnson

Product:
Classification Name: Surgical Apparel (21 CFR 878.4040)
Generic Name: Apron
Trade/Proprietary Name: Disposable Apron

## Substantially Equivalent Product:

Sloan Medical, Disposable Surgical Jumpsuit
Associated Bag, Apron

## Description:

The Disposable Apron is manufactured from 6 gauge Poly Vinyl and is available in a “one size fits most” size. The apron is secured by being slipped over the head and tied in back

## Intended Use:

The Disposable Apron will be used in indications which are the same for that of other aprons. Specifically, the Disposable Apron is intended to be used the hospital environment to protect the healthcare worker from the transfer of micro-organisms, blood, body fluids and particulate material between the worker and the patient

The Disposable Apron is a disposable product intended for single use only.

## Summary of the non-clinical tests from which substantial equivalence:

The Disposable Apron has the same intended use as Sloan Medical’s Disposable Surgical Jumpsuit and Associated Bag’s Apron. The designs are similar in that they both are secured around the neck and tied behind the back. The also cover the front of the body. The following table summarizes the non-clinical tests from which the substantial equivalence is based.

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K964364

| | Sloan Medical
Iumpsuit | Associated Bag
Apron | Instrument Makar
Apron |
| --- | --- | --- | --- |
| Intended Use | Protect user from fluids
in hospital environment | Protect user from fluids
in hospital environment | Protect user from fluids
in hospital environment |
| Design | Ties around the neck
and behind the back | Ties around the neck
and behind the back | Ties around the neck
and behind the back |
| Materials | 2 mil Polyethylene | 1 1/4 mil Polyethylene | 6 Gauge Embossed
Poly-Vinyl |
| Physical Safety | NA | NA | NA |
| Target Population | Hospital Personnel | Hospital Personnel | Hospital Personnel |
| Biocompatibility | Jumpsuit is worn over
clothing, therefore will
not be in contact with
user's skin | Apron is worn over
clothing, therefore will
not be in contact with
user's skin | Apron is worn over
clothing, therefore will
not be in contact with
user's skin |
| Anatomical Sites | Cover front of body and
feet | Cover front of body and
feet | Cover front of body and
feet |
| Additional Notes | Sold non-sterile | Sold non-sterile | Sold non-sterile |

## Summary of the Viral Penetration Test: ASTM Method F1671-95

The material from which the Apron is made, 6 gauge embossed Poly-Vinyl, is the same as Instrument Makar's Fluid Barrier Boots(K955835) are made.

## Summary:

The oX174 bacteriophage challenge suspension will be maintained at a concentration of at least 1.0 X 108 PFU/mL (plaque forming units/mL).

Test samples were prepared by randomly cutting approximately 75mm x 75mm test swatches from the test material. Test samples were challenged with approximately 60 mL of a oX174 bacteriophage suspension for 5 minutes at atmospheric pressure, 1 minute at 2.0 PSIG (13.8 kpa), and 54 minutes at atmospheric pressure or until liquid penetration was observed. At the conclusion of the test, the observed side of the test sample was rinsed with a sterile assay medium and then assayed for the presence of the oX174 bacteriophage. The surface tension of the challenge suspension and the assay medium was adjusted to approximately 40-44 dynes/cm using surf actant-type Tween® 80 at a final concentration of approximately 0.01% by volume.

These samples were also tested for compatibility of materials and test organisms. This testing was done by placing a 10 uL aliquot of a oX174 suspension containing a total of 900-1200 PFU near the center of the test sample after it had been clamped into the penetration test cell. After 60 minutes, the surface was rinsed with a sterile assay medium and then assayed for the presence of the oX174 bacteriophage.

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K964364

# Results

The compatibility ratio for the Fluid Barrier Boot was 1.3. The challenge level was maintained at -1.3 x 108 PFU/ml

Thirty two samples of the Fluid Barrier Boot were tested according to the procedure described in this report. All thirty two passed showing no oX174 on the assay plates.

TOTAL P.04