MASTER & FRANK SURGICAL GOWNS (STERILE)

K012186 · Master & Frank Ent. Co., Ltd. · FYA · Dec 7, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K012186
• Device Name: MASTER & FRANK SURGICAL GOWNS (STERILE)
• Applicant: Master & Frank Ent. Co., Ltd.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Dec 7, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Master & Frank Surgical Gowns (Sterile) is a single use article of surgical apparel 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.

Device Story

Master & Frank Surgical Gowns are single-use, non-woven fabric garments designed for operating room personnel. The gowns act as a physical barrier to prevent the transfer of microorganisms, body fluids, and particulate material between the surgical patient and the operating room staff. The device is used in clinical surgical settings. It provides protection to both the patient and the healthcare provider during procedures.

Clinical Evidence

Bench testing only. The device was evaluated against physical specifications (ASTM D1424, ASTM D5034, NFPA flammability standards), biological specifications (ISO 10993 series), and sterilization specifications (ISO 11137 and ISO 11607-1).

Technological Characteristics

Non-woven fabric construction. Designed to meet ASTM D1424 (tear resistance), ASTM D5034 (breaking strength), and NFPA flammability standards. Biocompatibility per ISO 10993. Sterilization per ISO 11137 and ISO 11607-1. Single-use, sterile.

Indications for Use

Indicated for use by operating room personnel during surgical procedures to protect the patient and personnel from the transfer of microorganisms, body fluids, and particulate material. Single use only.

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

• Medline Disposable Surgical Drapes & Gowns (K964142)

Submission Summary (Full Text)

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# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the K 012186 requirements of SMDA and 21 CFR §807.92

| | | DEC 0 7 2001 |
|----|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| i. | Submitter's Name: | Master & Frank Enterprise Co., Ltd. |
| | Address: | 15F-1, No. 57, Sec. 2, Tun Hea S. Rd. Taipei, Taiwan, R.O.C. |
| | Phone: | 886-2-2325-5066 |
| | Fax: | 886-2-2702-6577 |
| | Contact: | Mr. Frank Wu (General Manager) |
| | 2. Device Name | |
| | Trade Name: | Master & Frank Surgical Gowns(Sterile) |
| | Common Name: | Sterile Surgical Gowns |
| | Classification name: | GOWN , SURGICAL |
| 3. | Classification: | Class II |
| 4. | Predicate Device: | Medline Disposable Surgical Drapes & Gowns ( K964142 ) |
| 5. | Device Description: | Master & Frank Surgical Gowns (Sterile), is manufactured from non-woven |
| | | fabric. This surgical Gown is supplied sterile and for single use only. |
| 6. | Intended Use: | Master & Frank Surgical Gowns (Sterile) is a single use article of surgical<br>apparel worn by operating room personnel during surgical procedures to protect<br>both the surgical patient and the operating room personnel from transfer of<br>microorganisms, body fluids, and particulate material. |
| | | 7. Performance Summary: In terms of Physical specification -- ASTM D1424 , ASTM D5034 & NFPA<br>Flammability standards----etc, Biological specification ISO 10993 series &<br>Sterilization Specification ISO 11137 & ISO 11607-1 , the device are designed to<br>meet applicable standards.. |

#### 8. Conclusions:

The Master & Frank Surgical Gowns (Sterile) have the same intended use and similar technological characteristics as the Medline Disposable Surgical Drapes & Gowns ( K964142 ). Moreover, bench testing contained in this submission den:onstrate that any differences in their technological characteristics do Thus, the Master & Frank Surgical Gowns not raise any new questions of safety or effectiveness. (Sterile) is substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 0 7 2001

Master & Frank Enterprise Company Limited C/O Ms. Jennifer Reich Harvest Consulting, Incorporated 3892 South America West Trail Flagstaff, Arizona 86001

Re: K012186

R012100
Trade/Device Name: Master & Frank Surgical Gowns (Sterile) Regulation Number: 878.4040 Regulation Name: Sterile Surgical Gowns Regulatory Class: II Product Code: FYA Dated: November 20, 2001 Received: November 23, 2001

Dear Ms. Reich:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becalen 510(x) production is substantially equivalent (for the relerenced above and have decemined are to legally marketed predicate devices marketed in indications for use stated in the enoiosal of to enginent date of the Medical Device interstate conninetee pror to reay 20, 1970, consisted in accordance with the provisions of Amendinents, or to de vices that nave oose (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosmetic 110 (Pro) ------------------------------------------------------------------------------------------------------------------------------approval application (1 Mr.). - 1 ou ney, crowisions of the Act include controls provisions of the Fee. "The girling of devices, good manufacturing practice, requiremonts for alliations against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (500 a00 roy into seontrols. Existing major regulations affecting (PMA), it may be subject to Such address from Regulations, Title 21, Parts 800 to 898. In the Colors your device can oc found in the South of the could be of the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled of a bases and institution with other requirements mean that I DA nas made a deceminary and regulations administered by other Federal agencies.

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Page 2 - Ms. Reich

You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Act 3 requirements (21 CFR Part 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing p and listing (21 CFR Part 607), laceling (21 CFR Pat 820), and if requirements as sectionic me quality by stems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section This letter will anow you to ocgin maneting your substantial equivalence of your device to
510(k) premarket notification. The FDA finding of substantial equivalence and this 510(K) premarket notification. The FBFF in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 IT you desire specific ad rice for your for in vitro diagnostic devices), please contact the and additionally 21 CF R F art 6094-4618. Additionally, for questions on the promotion and Office of Comphance at (301) 591 - 1010. For of Compliance at [phone]. advertising or your arritled, "Misbranding by reference to premarket Also, prease note the regal 807.97). Other general information on your responsibilities under nothleation (ZTCI K Fart 007.97): Oaler general Manufacturers, International and the Act may be obtained from and Boumber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ulatowski

Timot Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### NUMBER (IF KNOWN): __ KO12 i S6 510 (k)

DEVICE NAME: Mater & Frank surgical Gowns (Sterile)

INDICATIONS FOR USE:

Master & Frank Surgical Gowns (Sterile) are single use article of surgical apparel that is intended to be worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Cver-The-Counter _____________________________________________________________________________________________________________________________________________________________ V (Optional Format)

Clim S. Lin

(Division Sign-Off) Division of Dental, Infection Control, arr General Hospital Devices S . C. J Number