(166 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 Ultimate is a powder free, sterile, Polychloroprene examination glove, tested for use with chemotherapy agents.
This document is a 510(k) summary for the BioClean Chemo Ultimate patient examination glove. It details the device's characteristics, intended use, and substantial equivalence to a legally marketed predicate device. The information provided is primarily related to the physical and chemical performance of the glove, not a software-based medical device. Therefore, many of the requested elements for describing the acceptance criteria and study for a software-based device are not applicable.
However, I can extract information related to the performance testing of the glove.
1. A table of acceptance criteria and the reported device performance
Based on the provided text and extracted table (Image /page/1/Picture/0), here is the information:
| Test/Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 6977-04 (specifications met) | Complies |
| Physical Properties | ASTM D 6977-04 (specifications met) | Complies |
| Freedom from Pinhole | ASTM D 6977-04 | AQL 2.5 |
| Powder Free | ASTM D 6977-04 | Max 2 mg/glove |
| Biocompatibility | ISO 10993 requirements met (cytotoxicity, irritation, sensitization) | Complies |
| Chemotherapy Drug Permeation (ASTM D 6978-05) | No breakthrough for at least 30 minutes (common industry standard for safe handling, though specific criteria are not explicitly stated for all drugs) | See table below |
Chemotherapy Drug Permeation Performance (from Image /page/1/Picture/0):
| Chemotherapy Agent | Concentration | Breakthrough Detection Time (minutes) |
|---|---|---|
| Carmustine (BiCNU) | 3.3 mg/mL | 9.8 |
| Cisplatinum | 1.0 mg/mL | > 480 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | > 480 |
| Dacarbazine (DTIC) | 10.0 mg/mL | > 480 |
| Doxorubicin HCl | 5.0 mg/mL | > 480 |
| Etoposide (Toposar) | 100.0 mg/mL | > 480 |
| 5-Fluorouracil | 50.0 mg/mL | > 480 |
| Ifosfamide (Ifex) | 50.0 mg/mL | > 480 |
| Methotrexate | 25.0 mg/mL | > 480 |
| Paclitaxel (Taxol) | 6.0 mg/mL | 18.2 |
| Thio-Tepa | 10.0 mg/mL | 47.7 |
| Vincristine | 1.0 mg/mL | > 480 |
| Cytarabine | 100.00 mg/mL | > 480 |
| Oxaliplatin | 5.00 mg/mL | > 480 |
| Gemcitabine HCl | 38.00 mg/mL | > 480 |
| Docetaxel | 10.00 mg/mL | 15.6 |
The remaining information requested is largely not applicable to this 510(k) submission for a non-software medical device like an examination glove. Here's why:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): While samples were used for physical and chemical testing, the document does not specify exact sample sizes for each test in a clinical trials context. Data provenance refers to the origin of medical data (e.g., patient records), which is not relevant here.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This pertains to expert review for diagnostic devices. For a glove, ground truth is established by standardized material testing following ASTM/ISO protocols, not expert consensus on medical images or diagnoses.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Adjudication is a process for resolving discrepancies in expert interpretations, again, not applicable to material testing of a glove.
- 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: This relates to comparative studies of diagnostic performance, specifically with AI assistance. Completely irrelevant for a patient examination glove.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This refers to the performance of an algorithm without human intervention, which is not relevant for a physical medical device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As noted in point 3, ground truth for a glove's performance is based on standardized physical and chemical tests, not clinical "ground truth" like pathology or outcomes.
- 8. The sample size for the training set: Training sets are used for machine learning models. This is not applicable to a physical glove.
- 9. How the ground truth for the training set was established: Ground truth for a training set is established for machine learning models. Not applicable for this device.
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Image /page/0/Picture/1 description: The image shows a logo with the letter 'n' in the center. The letter is in a simple, sans-serif font and appears to be the focal point of the design. Encircling the letter 'n' is some text, which is partially obscured but seems to follow the curve of the circle. The overall design is minimalist and likely represents a brand or organization with a name starting with the letter 'n'.
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,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 Ultimate | |
| Common name | Patient examination glove | |
| Classification name | Glove, Patient Examination, Specialty - 80LZC | |
| 7. | Legally marketed deviceto which equivalency isclaimed | The BioClean Chemo Ultimate is substantially Equivalent to thecurrent Class 1 Patient Examination Glove bearing the product code80LZC, 21 CFR 880.6250. It meets the current specifications ASTMD 6977-04 and has been tested for chemotherapy agent permeationperformance according to ASTM D 6978-05 |
| 8. | Description of device | The BioClean Chemo Ultimate is a powder free, sterile,Polychloroprene examination glove, tested for use withchemotherapy agents. |
| 9. | Intended use of thedevice | 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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Image /page/1/Picture/0 description: This image is a table summarizing the technological characteristics of a device, including non-clinical tests, standards, and performance. The table includes dimensions, physical properties, freedom from pinholes, powder-free status, biocompatibility, and resistance to permeation. It also lists chemotherapy agents tested and their concentrations, along with breakthrough detection times in minutes, such as Cisplatinum at 1.0 mg/mL with no breakthrough up to 480 minutes, and Thio-Tepa at 10.0 mg/mL with a breakthrough time of 47.7 minutes.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
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)
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
§ 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.