(266 days)
Powder-Free Blue Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between Examiner and Patient. Tested for use with Chemotherapy Drugs as listed below.
Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.
The provided document describes the FDA 510(k) clearance for "Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs" (K102623). It includes information about the indications for use and a table presenting the permeation times of various chemotherapy drugs through the gloves.
Based on the information provided, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the gloves, specifically regarding chemotherapy drug permeation, are implicitly defined by the reported breakthrough detection times in minutes for a list of chemotherapy drugs. Although explicit "acceptance criteria" values are not stated (e.g., "must be greater than X minutes"), the table presents the performance of the device against these drugs. The key benchmark for acceptability appears to be practical protection during use.
| Chemotherapy Drug | Acceptance Criteria (Implicit) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|
| 1. Carmustine | Not explicitly stated | 1.04 |
| 2. Cisplatin | Not explicitly stated | >240 |
| 3. Cyclophosphamide | Not explicitly stated | >240 |
| 4. Dacarbazine | Not explicitly stated | >240 |
| 5. Doxorubicin Hydrochloride | Not explicitly stated | >240 |
| 6. Etoposide | Not explicitly stated | >240 |
| 7. Flourouracil | Not explicitly stated | >240 |
| 8. Paclitaxel | Not explicitly stated | >240 |
| 9. Thiotepa | Not explicitly stated | 165 |
Note regarding Carmustine: The document explicitly states, "Please note that Carmustine has an extremely low permeation time of less than 30 minutes." This acts as an important cautionary note, implying that while the glove was tested with Carmustine, its performance for this specific drug is significantly lower than for others and might not meet a reasonable expectation for prolonged protection during chemotherapy handling.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the sample size (i.e., how many gloves were tested for each chemotherapy drug). It only presents the breakthrough detection times.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given that this is an FDA submission for a device manufactured by "PT. Medisafe Technologies JL. Batang Kuis GG. Tambak Rejo Desa Buntu Bedimbar TJ. Morawa Medan, North Sumatera Indonesia," it is highly probable that the testing was conducted either in Indonesia or at an accredited laboratory, but this is not confirmed by the document. The study would have been prospective to generate this performance data.
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 type of information is not applicable to this device. The "ground truth" for glove permeation is established through laboratory testing using standardized methods (e.g., ASTM F739 - Standard Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact). It does not involve human experts or their consensus for establishing the data in the permeation table.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to this device. Adjudication methods are typically used in studies involving subjective interpretation (e.g., radiology image reading). Glove permeation testing is an objective laboratory measurement.
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 information is not applicable to this device. An MRMC study is relevant for diagnostic devices that involve human interpretation, often assisted by AI. This is a protective barrier device, and its effectiveness is measured through physical and chemical property testing, not cognitive performance improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and is framed incorrectly for this device. A "standalone" performance refers to an AI algorithm's performance without human interaction. This device is a physical barrier; its performance is inherently standalone in the sense that its protective properties are measured intrinsically without human intervention in the permeation process itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance data presented is derived from objective laboratory testing using standardized chemical permeation methods. This involves measuring the time it takes for specific chemotherapy drugs to permeate through the glove material under controlled conditions. This is a scientific measurement, not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not applicable to this device. "Training set" refers to data used to train machine learning models. This device is not an AI/ML device; its performance is based on intrinsic material properties.
9. How the ground truth for the training set was established
This information is not applicable to this device, as there is no training set involved.
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Image /page/0/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, composed of thick, curved lines. The eagle's head is facing to the left, and its tail feathers are depicted with a wavy, flowing design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Anil Taneja Chief Executive Officer PT. Medisafe Technologies JL. Batang Kuis GG. Tambak Rejo Desa Buntu Bedimbar TJ. Morawa Medan, North Sumatera Indonesia 20362
JUN - 6 2011
Re: K102623
Trade/Device Name: Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA, LZC Dated: May 16, 2011 Received: May 23, 2011
Dear Mr. Taneje:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Taneja
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Cintmony D. Water
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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ATTACHMENT B
Indications for Use
Applicant : Medisafe Technologies
510(k) Number (if known): Not Known
Device Name: Powder-Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs.
Indications For Use:
Powder-Free Blue Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between Examiner and Patient. Tested for use with Chemotherapy Drugs as listed below.
| Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes.The following chemicals have been tested with these gloves | ||
|---|---|---|
| 1 | Carmustine | 1.04 |
| 2 | Cisplatin | >240 |
| 3 | Cyclophosphamide | >240 |
| 4 | Dacarbazine | >240 |
| 5 | Doxorubicin Hydrochloride | >240 |
| 6 | Etoposide | >240 |
| 7 | Flourouracil | >240 |
| 8 | Paclitaxel | >240 |
| 9 | Thiotepa | = 165 |
Please note that Carmustine has an extremely low permeation time of less than 30 minutes.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR .
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth T. Clarence-Williams
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K102623
§ 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.