(103 days)
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No
The summary describes a disposable medical glove and does not mention any AI or ML capabilities.
No
Explanation: The device, a disposable examination glove, is intended for preventing contamination between patient and examiner, and is tested for use with chemotherapy drugs. It does not treat or alleviate any disease, injury, or medical condition, which are characteristics of a therapeutic device.
No
Explanation: This device is a glove, a barrier intended to prevent contamination between a patient and an examiner. Its function is protective, not diagnostic. It does not gather any information about a patient's health condition.
No
The device is a physical glove, not software. The description clearly indicates it is a "Powder Free Nitrile Examination Glove".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the glove is "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details the physical characteristics of the glove and its testing for chemotherapy drug resistance. This aligns with a protective barrier device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information about a patient's health condition.
Therefore, this device falls under the category of a medical device, specifically a protective barrier, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove is tested for use with Dacarbazine (DTIC), Mitomycin C, Methotrexate, Cyclophosphamide (Cytoxan), Mitoxantrone, Doxorubicin Hydrochloride, Ifosfamide (Ifex), 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol), Vincristine Sulfate
Warning: Not Recommended For Use With Carmustine and Thio-Tepa
Product codes
LZA, LZC
Device Description
Powder Free Nitrile Examination Glove (Pink, Green, Orange, White). This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole. Low Dermatitis Potential. Tested For Use With Chemotherapy Drugs.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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.
0
Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is centered in the image and is the only element present. The text is likely part of a document or presentation.
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, facing left. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2009
Mr. Foo Khon Pu Chief Executive Officer GX Corporation SDN BHD Lot 6487-A, Batu 5 34, Semnta, Jalan Kapar Klang Selangor Darul Ehsan MALAYSIA 42100
Re: K090412
Trade/Device Name: Powder Free Nitrile Examination Glove (Pink, Green, Orange, White), This Product Does Not Contain Thiuram, and/or Carbamate and /or Thiazole. Low Dermatitis Potential.
Tested For Use With Chemotherapy Drugs.
Regulation Number: 21 CFR 880,6250
Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: May 12, 2009 Received: May 14, 2009
Dear Mr. Pu:
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.
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Page 2- Ms. Mulnick
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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 vours.
Susan Tanner
Susan Runner, D.D.S., MA 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): K 090412
Powder Free Nitrile Examination Glove (Pink, Green, Orange, White). Device Name: This Product Does Not Contain Thiuram, and/or Carbamate and/or Thiazole, Low Dermatitis Potential. Tested For Use With Chemotherapy Drugs.
Indication For Use:
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
This glove is tested for use with Dacarbazine (DTIC), Mitomycin C, Methotrexate, Cyclophosphamide (Cytoxan), Mitoxantrone, Doxorubicin Hydrochloride, Ifosfamide (Ifex), 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol), Vincristine Sulfate
Warning: Not Recommended For Use With Carmustine and Thio-Tepa
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR ·
Over-The-Counter Use (21 CFR 801 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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