NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE

K051094 · Terang Nusa Sdn Bhd · KGO · Jun 6, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K051094
• Device Name: NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE
• Applicant: Terang Nusa Sdn Bhd
• Product Code: KGO · General, Plastic Surgery
• Decision Date: Jun 6, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4460
• Device Class: Class 1

Intended Use

NUZONE X2T surgical gloves are disposable and sterile devices intended to be worn by healthcare personnel to prevent cross contamination between the user and the patient during procedures.

Device Story

NUZONE X2T is a sterile, powder-free, polymer-coated polychloroprene synthetic surgical glove. Used by operating room personnel to prevent cross-contamination between user and patient during surgical procedures. Device acts as a physical barrier. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ASTM D 3577-01ae2 (physical properties), ASTM D512, ASTM F 719-81 (primary skin irritation), and ASTM F 720-81 (dermal sensitization) demonstrated no irritation or sensitization.

Technological Characteristics

Material: Polychloroprene synthetic rubber. Form: Powder-free, polymer-coated, tan-colored surgical glove. Standards: ASTM D 3577-01a², ASTM F 719-81, ASTM F 720-81. Sterilization: Sterile. Connectivity: None. Energy source: None.

Indications for Use

Indicated for use by operating room personnel to protect a surgical wound from contamination. Device is a synthetic rubber glove; lubricating or dusting powder is excluded.

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

• NUZONE X2 Neoprene - Polyisoprene synthetic powderfree surgical glove (K041436)

Submission Summary (Full Text)

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### JUN 6 - 2005 TERANG NUSA Sdn Bhd

510(k) Submission for NUZONE X2T Surgical Glove Powderfree

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# SPECIAL 510(k) Summary

| Submitter Name | Terang Nusa Sdn Bhd |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address | 1, Jalan 8<br>Pengkalan Chepa 2 Industrial Zone<br>16100 Kota Bharu,<br>Kelantan, Malaysia. |
| Submitter Telephone | [phone] |
| Submitter Fax | [phone] |
| Contact Person | LOW, Chin Guan |
| Date of preparation | 22. April 2005 |
| Trade Name | NUZONE X2T |
| Common Name | Sterile Polychloroprene Synthetic surgical glove,<br>Powderfree, Polymer coated Tan color. |
| Classification | Surgeon's Glove |
| Description of Device<br>Modification: | The NUZONE X2T, described in this SPECIAL<br>510(k) is substantially equivalent to the NUZONE<br>X2 Neoprene - Polyisoprene synthetic powderfree<br>surgical glove that is currently marketed and<br>cleared under 510(K) number K041436. |
| Description of device | NUZONE X2T, powderfree surgical glove meets<br>the requirements for surgical gloves described by<br>the American Standard for Testing and Material<br>ASTM D 3577 - 01a² |
| Intended Use of the device | NUZONE X2T surgical gloves are disposable<br>and sterile devices intended to be worn by<br>healthcare personnel to prevent cross<br>contamination between the user and the patient<br>during procedures. |

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## TERANG NUSA San Bhd

510(k) Submission for NUZONE X2T Surgical Glove Powderfree

のお気になる。

Comments of Children and Children and

September 1998 - 1999

#### 510 K Summary ( continued)

| Brief description of non-clinical tests | Test conducted per ASTM D 3577 - 01ae2, ASTM D512 indicates that the product meet the requirements.<br>Primary Skin Irritation test ASTM F 719-81 and Dermal Sensitization Test ASTM F 720-81 (86) indicates no sensitization or irritation. |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Brief description of clinical tests | Not required |
| Conclusion drawn from clinical and non clinical tests | It can be concluded that NUZONE X2T Polychloroprene synthetic powderfree surgical glove will perform according to the performance standards referenced and therefore meets ASTM standards. FDA requirements and labeling claims.<br>This device is substantially equivalent to the currently marketed devices. |
| Additional information deemed necessary by the FDA | None |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 6 - 2005

Mr. Low Chin Guan Managing Director Terang NUSA Sdn Bhd 1 Jalan 8 Pengkalan Chepa 2 Industrial Zone Kota Bharu, 16100 MALAYSIA

Re: K051094

K031094
Trade/Device Name: Polychlorprene Synthetic Tan Surgical Glove Powder Free Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: May 17, 2005 Received: May 23, 2005

Dear Mr. Chin-Guan:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed yoursely and have determined the device is substantially equivalent (for the referenced above and have acteriminosure) 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 Annehumens, or to do rood alla time ic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin uppression (the Act. The general controls provisions of the Act include controls provisions of the stration, 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 If your dovice is classified (been additional controls. Existing major regulations affecting (1 MA), it may of such adde of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or routish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Chin-Guan

Please be advised that FDA's issuance of a substantial equivalence determination does not Fleast be auvrsou that 1 Dr. determination that your device complies with other requirements mean that I DA mas made a decessand regulations administered by other Federal agencies. Of the Act of ally 1 ederal titled the equirements, including, but not limited to: registration 1 ou thust comply with an art are rabeling (21 CFR Part 801); good manufacturing practice and listing (21 CF R Part 807), aquality systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality sion 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) This letter will anow you to begin mains of substantial equivalence of your device to a premarket notification. The PDF innalis 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), If you desire specific at no for your 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 Inay other beloner beliefers, 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,

Shi-Jian Liu, 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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### Indications for Use

510(k) Number (if known): K051094

Device Name: Polychlorprene Synthetic Tan Surgical Glove Powder Free

Indications For Use:

This Sugeon's Glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shila T. Murphy, MD 5/25/05

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

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510(k) Number: A051194