BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES
Device Facts
| Record ID | K081971 |
|---|---|
| Device Name | BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES |
| Applicant | Nitritex (M) Sdn. Bhd. |
| Product Code | LZC · General Hospital |
| Decision Date | Dec 23, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
Indications for Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with Chemotherapy Drugs
Device Story
BioClean Chemo Ultimate is a sterile, powder-free, polychloroprene patient examination glove. Designed for use by healthcare professionals in clinical settings to provide a barrier against contamination between patient and examiner. Device is tested for permeation resistance against specific chemotherapy agents per ASTM D 6978-05. Provides protection during handling of chemotherapy drugs; helps maintain sterile field and prevent cross-contamination.
Clinical Evidence
Bench testing only. Device tested for physical properties, freedom from pinholes, and chemotherapy agent permeation resistance according to ASTM D 6977-04 and ASTM D 6978-05. Permeation testing included various chemotherapy agents (e.g., Cisplatinum, Thio-Tepa) with reported breakthrough detection times.
Technological Characteristics
Material: Polychloroprene. Form factor: Sterile, powder-free examination glove. Standards: ASTM D 6977-04 (general glove specs), ASTM D 6978-05 (chemotherapy permeation).
Indications for Use
Indicated for use as a disposable patient examination glove worn by medical examiners to prevent cross-contamination between patient and examiner; tested for use with chemotherapy drugs.
Regulatory Classification
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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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## Registration Number k081971 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
## BioClean Chemo Ultimate
| 1. | Submitter's name | Nitritex (M) Sdn. Bhd. |
|----|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Submitter's address | Lot 2935B, Kampung Batau 9 Kebun Baru,<br>Jalan Masjid, 42500 Teluk Panglima Garang,<br>Selangor Darul Ehsan, Malaysia |
| 3. | Telephone | 603-3122 2614 |
| 4. | Fax | 603-3122 6331 |
| 5. | Date of preparation | 17 November 2008 |
| 6. | Name of device: | |
| | Trade Name | BioClean Chemo Ultimate |
| | Common name | Patient examination glove |
| | Classification name | Glove, Patient Examination, Specialty - 80LZC |
| 7. | Legally marketed device<br>to which equivalency is<br>claimed | The BioClean Chemo Ultimate is substantially Equivalent to the<br>current Class 1 Patient Examination Glove bearing the product code<br>80LZC, 21 CFR 880.6250. It meets the current specifications ASTM<br>D 6977-04 and has been tested for chemotherapy agent permeation<br>performance according to ASTM D 6978-05 |
| 8. | Description of device | The BioClean Chemo Ultimate is a powder free, sterile,<br>Polychloroprene examination glove, tested for use with<br>chemotherapy agents. |
| 9. | Intended use of the<br>device | A patient examination glove is a disposable device intended for<br>medical purposes that is worn on the examiner's hand or finger to<br>prevent contamination between patient and examiner.<br>Tested for use with Chemotherapy Drugs |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Derek Watts Director Nitritex (M) Sdn. Bhd. Lot 2935B, Kg. Batu 9 Kebun Baru, Jin Masjid Telok Panglima Garang Kuala Langat, Selangor DE MALAYSIA 42500
DEC 2 3 2008
Re: K081971
Trade/Device Name: BioClean Chemo Ultimate Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC Dated: November 27, 2008 Received: December 5, 2008
Dear Mr. Watts:
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 Amendments, 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 controls provisions 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 your device can 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. Watts
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions-regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html,
Sincerely yours.
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)
K081971
Device Name
BioClean Chemo Ultimate
Indications For Use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Tested for use with Chemotherapy Drugs
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
x
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shula A. Murphy, Llc
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K081971
