MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE

K050071 · H.B.M. USA Co.,Inc. · KGO · May 11, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050071
• Device Name: MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE
• Applicant: H.B.M. USA Co.,Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: May 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

MEDISPO powdered surgeon's gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants. MEDISPO-PF powder-free surgeon's gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to he worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Device Story

Sterile, disposable natural rubber latex gloves; designed for use in surgical settings; provide barrier protection against infectious materials and contaminants. MEDISPO version includes powder to facilitate donning; MEDISPO-PF version is powder-free (may contain trace amounts). Worn on hands by surgeons and clinical staff. Performance verified against ASTM D3577 standards.

Clinical Evidence

Bench testing only. Product tested per ASTM D3577 requirements; results indicate compliance with performance standards. Testing also confirmed no sensitization or irritation.

Technological Characteristics

Natural rubber latex material; sterile; disposable; form factor: surgical gloves; performance compliant with ASTM D3577.

Indications for Use

Indicated for use by healthcare professionals in surgical settings as a sterile, disposable natural rubber latex barrier to protect against infectious materials and contaminants.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• POWDERED LATEX SURGEON'S GLOVES by CEPHAS MEDICAL
• MAXTER STERILE POWDER FREE SURGICAL GLOVES

Submission Summary (Full Text)

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H.B.M. USA Co., Inc. – Abbreviated 510k application for Latex Sterile Surgical Gloves

MAY 1 1 2005

## KOSOOTI

510(k) Summary/Statement Requirement

| DEVICE NAME | Powdered and Powder-Free Latex Surgical Gloves |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION | Class I, 21CFR878.4460 |
| TRADE NAME | MEDISPO and MEDISPO-PF |
| DEVICE DESCRIPTION | MEDISPO and MEDISPO-PF meet the requirements<br>for surgical gloves described by ASTM D3577. |
| APPLICANT | H.B.M. USA Co., Inc.<br>HBM Building<br>98-02 218 Street<br>Queens Village, NY 11429<br><br>Contact Person<br>Gordon X. Hu, President<br>[phone] Ph.<br>[phone] Fax |
| PREDICATE DEVICE | This product is already approved and for sale in the<br>European Union and refers to various surgeon's<br>gloves already on the market in the US as predicate<br>devices including: POWDERED LATEX SURGEON'S<br>GLOVES by CEPHAS MEDICAL and MAXTER<br>STERILE POWDER FREE SURGICAL GLOVES. |
| INDICATIONS FOR USE | MEDISPO powdered surgeon's gloves are sterile<br>disposable devices made of natural rubber latex that<br>bears powder to facilitate donning, and it is intended<br>to be worn on the hands, usually in surgical settings,<br>to provide a barrier against potentially infectious<br>materials and other contaminants.<br><br>MEDISO-PF powder-free surgeon's gloves are sterile<br>disposable devices made of natural rubber latex that<br>may bear a trace amount of glove powder and is<br>intended to be worn on the hands, usually in surgical<br>settings, to provide a barrier against potentially<br>infectious materials and other contaminants. |
| TESTING | Tests conducted per ASTM D3577, indicate that the<br>product meets the requirements. Tests also indicate<br>no sensitization or irritation. |
| CONCLUSION | It can be concluded that MEDISPO and MEDISPO-<br>PF surgical gloves will perform according to the<br>performance standards referenced and therefore<br>meet ASTM standards, FDA requirements and<br>labeling claims. This device is substantially<br>equivalent to currently marketed devices. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure.

MAY 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gordon X. Hu President H.B.M. USA Company, Incorporated HBM Building, 98-02, 218 Street Queens Village, New York 11429

Re: K050071

Trade/Device Name: MEDISPO Powdered Surgeon's Gloves and MEDISPO-PF Powder-free Surgeon's Gloves Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: April 14, 2005 Received: April 19, 2005

Dear. Mr. Hu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinona, of to arrand Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions or a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 MA), it may of subject to back and frederal Regulations, Title 21, Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Hu

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease of act FDA has made a determination that your device complies with other requirements mount that I Drima many Federal statutes and regulations administered by other Federal agencies. or the For or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and home (21 er er read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bectronic product radiation control provisions (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 510(k) I mis letter will and in J . The FDA finding of substantial equivalence of your device to a premails and the redicate device results 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), 11 you dontact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj overnit Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu-Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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H.B.M. USA Co., Inc. - Abbreviated 510k application for Latex Sterile Surgical Gloves Amended on 04.12.05

## Indications for Use Statement 3.0

Indications for Use

510(k) Number (if known): K050071

Device Name: MEDISPO powdered surgeon's gloves and MEDISPO-PF powder-free surgeon's gloves

Indications For Use:

MEDISPO powdered surgeon's gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

MEDISPO-PF powder-free surgeon's gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to he worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

X Over-The-Counter Use (21 CFR 801 Subpart C)

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