(244 days)
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
The BioClean Chemo Shield is a powder free, sterile, Polychloroprene examination glove, tested for use with chemotherapy agents.
The BioClean Chemo Shield is a patient examination glove. The acceptance criteria and performance data for this device are detailed in the provided document, primarily focusing on non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test (Standard) | Performance |
|---|---|
| Dimensions (ASTM D 6977-04) | Met |
| Physical properties (ASTM D 6977-04) | Met |
| Freedom from pinholes (ASTM D 6977-04) | Met |
| Freedom from pinholes (ASTM D 5151-06) | Met |
| Powderfree (ASTM D 6124-06) | Met |
| Biocompatibility (ISO 10993-10: 2002) | Met |
| Resistance to permeation (ASTM D 6978-05) | Breakthrough Detection Time (minutes) |
| Cisplatinum, 1.0 mg/mL | No Breakthrough up to 480 |
| Carmustine, 3.3 mg/mL | 50.3 |
| Cyclophosphamide, 20.0 mg/mL | No Breakthrough up to 480 |
| DoxorubicinHydrochloride | No Breakthrough up to 480 |
| 5-Fluorouracil, 50.0 mg/mL | No Breakthrough up to 480 |
| Methotrexate, 25.0 mg/mL | No Breakthrough up to 480 |
| Etoposide, 20.0 mg/mL | No Breakthrough up to 480 |
| Paclitaxel (Taxol), 6.0 mg/mL | No Breakthrough up to 480 |
| Thio-Tepa, 10.0 mg/mL | 107.7 |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of gloves tested for pinholes, dimensions, or permeation). The data provenance is derived from laboratory testing against established ASTM and ISO standards, indicating a controlled, prospective testing environment rather than retrospective data. The location of the submitter, Nitritex (M) Sdn. Bhd., is Malaysia, so the testing could have occurred there or at a certified lab elsewhere.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for these non-clinical tests is established by standardized testing protocols (ASTM, ISO) and laboratory measurements rather than expert human interpretation.
4. Adjudication method for the test set:
Not applicable. The reported performance metrics are objective measurements from standardized tests, not subjective interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a patient examination glove, and its performance is evaluated through non-clinical laboratory testing, not through human reader interpretation or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical product (a glove), not an algorithm or AI system.
7. The type of ground truth used:
The ground truth used for the device's acceptance criteria is based on established industry standards and laboratory measurements. For physical properties, it's defined by the specifications outlined in ASTM D 6977-04. For freedom from pinholes, it's ASTM D 6977-04 and ASTM D 5151-06. For powder content, it's ASTM D 6124-06. For biocompatibility, it's ISO 10993-10: 2002. Notably, for resistance to chemotherapy agent permeation, the ground truth is the chemical breakthrough detection time as measured according to ASTM D 6978-05.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this product.
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MAR 1 1 2009
Image /page/0/Picture/1 description: The image shows a logo with the letter 'n' inside a circle. Below the logo, there is a series of numbers and letters, 'K681970'. The text is in a simple, sans-serif font and appears to be part of a serial number or identification code.
Registration Number K081970
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
BioClean Chemo Shield
| 1. | Submitter's name | Nitritex (M) Sdn. Bhd. |
|---|---|---|
| 2. | Submitter's address | Lot 2935B, Kampung Batau 9 Kebun Baru,Jalan Masjid, 42500 Teluk Panglima Garang,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 Shield | |
| Common name | Patient examination glove | |
| Classification name | Glove, Patient Examination, Specialty - 80LZC | |
| 7. | Legally marketed device to which equivalency is claimed | The BioClean Chemo Shield is substantially Equivalent to the currentClass 1 Patient Examination Glove bearing the product code 80LZC,21 CFR 880.6250. It meets the current specifications ASTM D 6977-04 and has been tested for chemotherapy agent permeationperformance according to ASTM D 6978-05 |
| 8. | Description of device | The BioClean Chemo Shield is a powder free, sterile,Polychloroprene examination glove, tested for use withchemotherapy agents. |
| 9. | Intended use of the device | A patient examination glove is a disposable device intended formedical purposes that is worn on the examiner's hand or finger toprevent contamination between patient and examiner.Tested for use with Chemotherapy Drugs |
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| 10. Summary ofTechnologicalcharacteristics of thedevice | Non-clinical tests | Standard | Performance |
|---|---|---|---|
| Dimensions | ASTM D 6977-04 | Met | |
| Physical properties | ASTM D 6977-04 | Met | |
| Freedom from pinholes | ASTM D 6977-04 | Met | |
| ASTM D 5151-06 | Met | ||
| Powderfree | ASTM D 6124-06 | Met | |
| Biocompatibility | ISO 10993-10: 2002 | Met | |
| Resistance to permeation | ASTM D 6978-05 | See Data Below | |
| Chemotherapy agent testedand concentration | Breakthrough detection time(minutes) | ||
| Cisplatinum, 1.0 mg/mL | No Breakthrough up to 480 | ||
| Carmustine, 3.3 mg/mL | 50.3 | ||
| Cyclophosphamide, 20.0 mg/mL | No Breakthrough up to 480 | ||
| DoxorubicinHydrochloride | No Breakthrough up to 480 | ||
| 5-Fluorouracil, 50.0 mg/mL | No Breakthrough up to 480 | ||
| Methotrexate, 25.0 mg/mL | No Breakthrough up to 480 | ||
| Etoposide, 20.0 mg/mL | No Breakthrough up to 480 | ||
| Paclitaxel (Taxol), 6.0 mg/mL | No Breakthrough up to 480 | ||
| Thio-Tepa, 10.0 mg/mL | 107.7 | ||
| 11. Brief description ofclinical tests | No new clinical tests were required to support this 510(k) application | ||
| 12. Conclusions from thenon-clinical and clinicaltests | The testing carried out confirms that the BioClean Chemo Shield isas safe, as effective and perform as well as the glove performancestandards referenced in 10, above and can, therefore be classifiedas:Glove, Patient Examination, Specialty - 80LZC | ||
| 13. Other informationdeemed necessary byFDA | None |
and the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of the
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person, with the figures represented by flowing lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2009
Mr. Derek Watts Nitritex (M) Sdn. Bhd. Lot 2935B, Kampung Batu 9 Kebun Baru, Jalan Masjid 42500 Teluk Panglima Garang Selangor Darul Ehsan MALAYSIA
Re: K081970
Trade/Device Name: BioClean Chemo Shield Regulation Number: 21 CFR 880.6250 Regulation Name; Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 5, 2009 Received: March 9, 2009
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) 276-0120. 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.
Sinute H. Michau Omd.
Ginette Y. Michaud, M.D. Acting 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) K081970
Device Name
BioClean Chemo Shield
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
પ્ર Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Shila A. Murphy, MD
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
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§ 880.6250 Non-powdered patient examination glove.
(a)
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.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.