(87 days)
Not Found
Not Found
No
The device is a simple examination glove and the summary contains no mention of AI or ML.
No
Explanation: This device, nitrile examination gloves, is intended to prevent contamination between patient and examiner. Its function is protective rather than therapeutic; it does not directly treat or diagnose a medical condition.
No
The device is described as an examination glove intended to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical product (nitrile gloves) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are worn on the examiner's hand to prevent contamination between patient and examiner. This is a barrier function, not a diagnostic function performed in vitro (outside the living body).
- Device Description: The description confirms they are examination gloves.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on breakthrough times with chemotherapy drugs, which relates to the barrier function and safety for the user, not a diagnostic outcome.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes
LZA, LZC
Device Description
Nitrile Powder Free Examination Gloves (Blue) Tested for use with Chemotherapy Drugs - VBLU
Nitrile Powder Free Examination Gloves (Blue) Tested for use with Chemotherapy Drugs - ABLU
Blue Powder Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs) - CBLU
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical and dental 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is facing left and has three lines above it, possibly representing the three branches of government.
DEPARTMENT OF HEALTH & HUMAN SERVICES
SEP - 4 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring MD 20993-0002
Ms. Nurul Aisyah Kong Bt Abdullah Quality Assurance Manager Hartalega Sdn. Bhd. No. 7 Kawasan Perusahaan Suria Bestari Java, Selangor 45600 MALAYSIA
Re: K091652
Trade/Device Name: Nitrile Powder Free Examination Gloves (Blue) Tested for use with Chemotherapy Drugs - VBLU
Nitrile Powder Free Examination Gloves (Blue) Tested for use with Chemotherapy Drugs - ABLU
Blue Powder Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs) - CBLU
Regulation Number: 21 CFR 880.6250
Regulation Name: Patient Examination Glove
Regulatory Class: I Product Code: LZA, LZC
Dated: August 12, 2009 Received: August 18, 2009
Dear Ms. Kong:
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 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.
1
Page 2- Ms. Kong
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/CDRH Offices/ucm115809.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/Safety/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Anthony D'areton for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indication For Use
510(k) Number (if known) : K091652
Device Name :
Nitrile Powder Free Examination Gloves (Blue) Tested for use with Chemotherapy Drugs -VBLU
Indications For Use :
The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.The list of chemotheraphy drugs tested (with breakthrough times) are as below:
| Chemotheraphy Drugs | Breakthrough Time (Minutes) |
|---|---|
| 1. Carmustine | 6.60 |
| 2. Cisplatin | > 240 |
| 3. Cyclophosphamide (Cytoxan) | > 240 |
| 4. Dacarbazine | > 240 |
| 5. Doxorubicin Hydrochloride | > 240 |
| 6. Etoposide | > 240 |
| 7. Fluorouracil | > 240 |
| 8. Methotrexate | > 240 |
| 9. Mitomycin | > 240 |
| 10. Paclitaxel | > 240 |
| 11. Thiotepa | 14.83 |
| 12. Vincristine Sulfate | > 240 |
"WARNING: Do not use with Carmustine and Thiotepa."
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)
Stucke H. M. Humphrey MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091452
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3
Indication For Use
510(k) Number (if known) : K091652
Device Name :
Nitrile Powder Free Examination Gloves (Blue) Tested for use with Chemotherapy Drugs -ABLU
Indications For Use :
The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The list of chemotheraphy drugs tested (with breakthrough times) are as below:
| Chemotheraphy Drugs | Breakthrough Time (Minutes) |
|---|---|
| 1. Carmustine | 35.80 |
| 2. Cisplatin | > 240 |
| 3. Cyclophosphamide (Cytoxan) | > 240 |
| 4. Dacarbazine | > 240 |
| 5. Doxorubicin Hydrochloride | > 240 |
| 6. Etoposide | > 240 |
| 7. Fluorouracil | > 240 |
| 8. Methotrexate | > 240 |
| 9. Mitomycin | > 240 |
| 10. Paclitaxel | > 240 |
| 11. Thiotepa | 85.48 |
| 12. Vincristine Sulfate | > 240 |
"CAUTION: Testing showed an average breakthrough time of 35.80 minutes with Carmustine."
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)
Shiela R. Murphy, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091652
Page 1 of
4
Indication For Use
510(k) Number (if known) : K091652
Device Name :
Blue Powder Free Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs) -CBLU
Indications For Use :
The nitrile examination gloves (Tested for use with Chemotheraphy Drugs) is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The list of chemotheraphy drugs tested (with breakthrough times) are as below:
| Chemotheraphy Drugs | Breakthrough Time (Minutes) |
|---|---|
| 1. Carmustine | 2.38 |
| 2. Cisplatin | > 240 |
| 3. Cyclophosphamide (Cytoxan) | > 240 |
| 4. Dacarbazine | > 240 |
| 5. Doxorubicin Hydrochloride | > 240 |
| 6. Etoposide | > 240 |
| 7. Fluorouracil | > 240 |
| 8. Methotrexate | > 240 |
| 9. Mitomycin | > 240 |
| 10. Paclitaxel | > 240 |
| 11. Thiotepa | 63.81 |
| 12. Vincristine Sulfate | > 240 |
"WARNING: Do not use with Carmustine."
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091652
Page 1 of