(147 days)
Not Found
Not Found
No
The 510(k) summary describes a latex examination glove and does not mention any AI or ML components or functionalities.
No
The device is described as an "examination glove" used to prevent contamination, which indicates it's a barrier device for protection, not a device that treats or alleviates a disease or condition.
No
The device is described as an examination glove intended to prevent contamination, not to diagnose a medical condition.
No
The device is a physical examination glove, not a software application. The description clearly indicates it is a "disposable device intended for medical purposes that is worn on the examiner's hand or finger".
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 device 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." This describes a barrier device used externally.
- Device Description: The description confirms it's a "Colored Powder Free Latex Examination Glove." This is a physical barrier.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment.
- Using reagents or other substances to perform a test.
The information about testing with chemotherapy drugs and breakthrough detection time relates to the performance and safety of the glove as a barrier, not its use as a diagnostic tool.
N/A
Intended Use / Indications for Use
A powder-free latex 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.
The tested chemotherapy drugs and their breakthrough detection time are as follows :
White Latex Powder Free
| Chemotherapy Drugs | Average BDT |
|---|---|
| Carmustine (BCNU) 3.3mg/ml | 15.2 |
| Cisplatin 1.0mg/ml | >240 min |
| Cyclophosphamide (Cytoxan) 20.0mg/ml | >240 min |
| Dacarbazine (DTIC) 10.0mg/ml | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml | >240 min |
| Etoposide ( Toposar) 20.0 mg/ml | >240 min |
| Fluorouracil 50.0 mg/ml | >240 min |
| Ifosfamide 50.0 mg/ml | >240 min |
| Methotrexate 25.0 mg/ml | >240 min |
| Mitomycin C 0.5 mg/ml | >240 min |
| Mitoxantrone 2.0 mg/ml | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 min |
| Thiothepa 10.0 mg/ml | 15.2 |
| Vincristine Sulfate 1.0 mg/ml | >240 min |
Please note that the following drugs have extremely low permeation times:
- Carmustine - 15.2 minutes
- Thiotepa - 15.2 Minutes
Blue Latex Powder.Free
Average Chemotherapy Drugs BDT
Carmustine (BCNU) 3.3mg/ml 5.7
Cisplatin 1.0mg/ml >240 min
Cyclophosphamide (Cytoxan) 20.0mg/ml >240 min
Dacarbazine (DTIC) 10.0mg/ml >240 min
Doxorubicin Hydrochloride 2.0 mg/ml >240 min
Etoposide ( Toposar) 20.0 mg/ml >240 min
Fluorouracil 50.0 mg/ml >240 min
Ifosfamide 50.0 mg/ml >240 min
Methotrexate 25.0 mg/ml >240 min
Mitomycin C 0.5 mg/ml >240 min
Mitoxantrone 2.0 mg/ml >240 min
Paclitaxel (Taxol) 6.0 mg/ml >240 min
Thiothepa 10.0 mg/ml 16.4
Vincristine Sulfate 1.0 mg/ml >240 min
Please note that the following drugs have extremely low permeation times:
- Carmustine - 5.7 minutes
- Thiotepa - 16.4 minutes
Product codes
LYY, LZC
Device Description
Not Found
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
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): 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.
Not Found
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.
Not Found
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).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tekmedic (M) Sdn Bhd Mr. Patrick Leong Chief Operation Officer Plot 4, Tanjung Kling Industrial Area Tanjung Bruas Jetty, Tanjung Kling Malacca, Malaysia 76400
Re: K121594
Trade/Device Name: Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm-
Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY, LZC Dated: October 18, 2012 Received: October 22, 2012
Dear Mr. Leong:
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.
OCT 25 2012
1
Page 2- Mr. Leong
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/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
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
Enclosure
2
Premarket Notification For Colored Powder Free Latex Examination Glove (White And Blue) Tested With Chemotherapy Drugs with A Protein Claim Of Less Than 50μg/Dm2
Indication For Use Statement · 4.0
K121594 510 (K) Number (if known) : ___
Device Name :
Colored Powder Free Latex Examination Glove (White and Blue) Tested With Chemotherapy Drugs With A Protein Claim Of Less Than 50ug/dm2
Indication For Use
A powder-free latex 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.
The tested chemotherapy drugs and their breakthrough detection time are as follows :
White Latex Powder Free
Blue Latex Powder.Free
| Chemotherapy Drugs | Average BDT |
|---|---|
| Carmustine (BCNU) 3.3mg/ml | 15.2 |
| Cisplatin 1.0mg/ml | >240 min |
| Cyclophosphamide (Cytoxan) 20.0mg/ml | >240 min |
| Dacarbazine (DTIC) 10.0mg/ml | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml | >240 min |
| Etoposide ( Toposar) 20.0 mg/ml | >240 min |
| Fluorouracil 50.0 mg/ml | >240 min |
| Ifosfamide 50.0 mg/ml | >240 min |
| Methotrexate 25.0 mg/ml | >240 min |
| Mitomycin C 0.5 mg/ml | >240 min |
| Mitoxantrone 2.0 mg/ml | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml | >240 min |
| Thiothepa 10.0 mg/ml | 15.2 |
| Vincristine Sulfate 1.0 mg/ml | >240 min |
Please note that the following drugs have extremely low permeation times:
-
Carmustine - 15.2 minutes
-
Thiotepa - 15.2 Minutes
Prescription Use Part 21 CFR 801 Subpart D
A verage Chemotherapy Drugs BDT Carmustine (BCNU) 3.3mg/ml 5.7 >240 min Cisplatin 1.0mg/ml >240 min Cyclophosphamide (Cytoxan) 20.0mg/ml >240 min Dacarbazine (DTIC) 10.0mg/ml Doxorubicin Hydrochloride 2.0 >240 min mg/ml >240 min Etoposide ( Toposar) 20.0 mg/ml >240 min Fluorouracil 50.0 mg/ml Ifosfamide 50.0 mg/ml >240 min >240 min Methotrexate 25.0 mg/ml >240 min Mitomycin C 0.5 mg/ml Mitoxantrone 2.0 mg/ml >240 min Paclitaxel (Taxol) 6.0 mg/ml >240 min 16.4 Thiothepa 10.0 mg/ml >240 min Vincristine Sulfate 1.0 mg/ml
Please note that the following drugs have extremely low permeation times:
-
Carmustine - 5.7 minutes
-
Thiotepa - 16.4 minutes
X Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE M NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)