(244 days)
80LZC
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML.
No.
The device is described as a "patient examination glove" intended to "prevent contamination between patient and examiner." Its function is preventative and protective, not therapeutic (i.e., it does not treat or cure a disease or medical condition).
No
The device is a patient examination glove, which is used for protection and not for diagnosing medical conditions.
No
The device is a physical examination glove, not a software application. The description clearly states it is a "disposable device intended for medical purposes that is worn on the examiner's hand or finger".
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This describes a barrier device used during physical examination or procedures, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description confirms it's a "powder free, sterile, Polychloroprene examination glove." This is consistent with a physical barrier device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring analytes
The testing mentioned ("Dimensions, Physical properties, Freedom from pinholes, Powderfree, Biocompatibility, and Resistance to permeation") are all related to the physical integrity and safety of the glove as a barrier, not its ability to diagnose or analyze.
This device falls under the category of a medical device, specifically a patient examination glove, as indicated by the predicate device information (21 CFR 880.6250).
N/A
Intended Use / 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
Product codes
LZC, LZA
Device Description
The BioClean Chemo Shield is a powder free, sterile, Polychloroprene examination glove, tested for use with chemotherapy agents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's, medical purposes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were performed.
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 tested and 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
No new clinical tests were required to support this 510(k) application.
Conclusions from the non-clinical and clinical tests: The testing carried out confirms that the BioClean Chemo Shield is as safe, as effective and perform as well as the glove performance standards referenced in 10, above and can, therefore be classified as: Glove, Patient Examination, Specialty - 80LZC.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
current Class 1 Patient Examination Glove bearing the product code 80LZC
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 current |
| Class 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 permeation | ||
| performance 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 with | ||
| chemotherapy agents. | ||
| 9. | Intended use of the device | 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 |
1
| 10. Summary of
Technological
characteristics of the
| device | 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 tested | |||
| and 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 of | |||
| clinical tests | No new clinical tests were required to support this 510(k) application | ||
| 12. Conclusions from the | |||
| non-clinical and clinical | |||
| tests | The testing carried out confirms that the BioClean Chemo Shield is | ||
| as safe, as effective and perform as well as the glove performance | |||
| standards referenced in 10, above and can, therefore be classified | |||
| as: | |||
| Glove, Patient Examination, Specialty - 80LZC | |||
| 13. Other information | |||
| deemed necessary by | |||
| FDA | 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
.
:
2
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.
3
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
4
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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