POWDERED LATEX SURGEON'S GLOVES

K031368 · Cephas Medical Private , Ltd. · KGO · Jun 22, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K031368
• Device Name: POWDERED LATEX SURGEON'S GLOVES
• Applicant: Cephas Medical Private , Ltd.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jun 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

A powdered surgeon's glove is a disposable device 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.

Device Story

Disposable natural rubber latex surgeon's glove; features powder coating to facilitate donning. Worn on hands by clinicians in surgical settings. Acts as physical barrier against infectious materials and contaminants. Protects both patient and healthcare provider during surgical procedures.

Clinical Evidence

No clinical data; device meets ASTM D 3577-00 requirements.

Technological Characteristics

Natural rubber latex; powdered for donning; disposable; meets ASTM D 3577-00 standards.

Indications for Use

Indicated for use by healthcare professionals in surgical settings as a protective barrier 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.

Submission Summary (Full Text)

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K031368

B-13, MEP2 - Special Economic Zone, Chennai - 600 045. INDIA. Tel.: [phone] Fax : [phone] E-mail : [e-mail] Website : www.cephas.trade-india.com

Image /page/0/Picture/2 description: The image contains two logos side-by-side. The logo on the left has an anchor above a scale, with the letters "DNV" below. The logo on the right has a triangle inside a circle, with the text "Accredited by the RvA" to the right. Below both logos, the text "ISO 9001: 2000 REGISTERED FIRM DNV Certification B.V. THE NETHERLANDS" is present.

## 1.0 510K SUMMARY

JUN 2 2 2004

CEPHAS MEDICAL

PRIVATE LIMITED

1.0 APPLICANT : NAME ADDRESS

PHONE NO FAX NO F MAIL

CONTACT PERSON

## DEVICE TRADE NAME COMMON NAME

l ægally marketed device to which the company claiming equivalence

- ි Intended use of the device
: CEPHAS MEDICAL PRIVATE LIMITED : B-13 MADRAS EXPORT PROCESSING ZONE TAMBARAM, CHENNAI - 600 045 INDLA 91 - 44 - 2262 1515 91 -- 44 -- 2262 1616 : [e-mail]

Mr. THANGIAH IMMANUFI. DIRECTOR

Powdered Latex Surgeon's Gloves Powdered Latex Surgeon's Gloves

Class I Surgeon's Gloves (Powdered) 79 KGO that meets all the requirements of ASTM D 3577 - 00

5 DESCRIPTION OF THE DEVICE :Class I Surgeon's Gloves (Powdered) 79 KGO that meets all the requirements of ASTM D 3577-00

> . A powdered surgeon's glove is a disposable device made of natural rubber lates 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.

| 7 Technological Characteristics of device | : Nil |
|----------------------------------------------------------------|-------|
| 8. The Determination of Substantial Equivalence | : Nil |
| 9 Assessment of Performance Data | : Nil |
| 10 The Conclusions Drawn from the non Clinical & Clinical Test | : Nil |
| 11 Any other information | : Nil |

Image /page/0/Picture/18 description: The image shows a circular stamp with the text "CEPHAS MEDICAL PVT. LTD." around the border. Inside the circle, the text "B13, MEPZ CHENNAI -600 045" is present. A star symbol is located at the bottom of the circle.

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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2004

Mr. Thangiah Immanuel Director Cephas Medical Private Limited B-13 Madras Export Processing Zone Tambaram Chennai Tamil Nadu, INDIA 600 045

Re: K031368

Trade/Device Name: Powdered Latex Surgeon's Gloves Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: 1 Product Code: KGO Dated: May 15, 2004 Received: May 21, 2004

Dear Mr. Immanuel:

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 referenced above and 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 the Federal Food, Drug, and 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 requirements for annual 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 wr 1), it ancan be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 -Mr. Immanuel

Please be advised that FDA's issuance of a substantial equivalence determination does not Please oe advisou that 1 DTT s issualled on that your device complies with other requirements mean that IDA has made a deceminations administered by other Federal agencies. of the Act of ally I edelar statues and reguirements, including, but not limited to: registration You must comply with an the Fice broq.21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laosing (21 CFR Part 820) regulation (21 CFR Part 820); and if requirents as set form in the quality bjoksions (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) This letter will anow you to begin mading of substantial equivalence of your device to a premaired predication. The PDF Intialing os 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 advice to: Jour de at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You entition, "Misoranamig of reservation on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Dristor [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Carl

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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## INDICATIONS FOR USE

| 510 (K) NUMBER | : |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME | : POWDERED LATEX SURGEON'S GLOVES |
| INDICATIONS FOR USE | : A powdered surgeon's glove is a disposable device 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. |

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

Over the Counter use ....... ( 21 CFR 801 Sub Part C )

Concurrence of CDRH Office of Device Evaluation (ODE )

Kei Ruby

(Division Sign-Off) Vision Sign-Oh)
Tision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K 031368