(285 days)
Not Found
Not Found
No
The summary describes a medical glove and its testing for chemotherapy drug permeation, with no mention of AI or ML.
No
The device is described as an examination glove intended to prevent contamination, not to provide therapy or treatment.
No
Explanation: The device is a patient examination glove used to prevent contamination, not to diagnose a medical condition. Its function is protective, not diagnostic.
No
The device is a physical examination glove, not a software application. The description clearly states 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 is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is a glove.
- Performance Studies: The performance studies focus on the glove's ability to resist permeation by chemotherapy drugs, which relates to its barrier function and safety for the user, not a diagnostic capability.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not fit that description.
N/A
Intended Use / 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.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drugs Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy | Concentration | Minimum Breakthrough Detection Time (min) |
|---|---|---|
| Fluorouracil (Adrucil) | 50.0mg/ml | >240 |
| Etopside(Toposar) | 20.0mg/ml | >240 |
| Cyclophosphamide(Cytoxan) | 20.0mg/ml | >240 |
| *Carmustine(BCNU) | 3.3mg/ml | 10.2 |
| *Thiotepa | 10.0mg/ml | 40.5 |
| Paclitaxel(Taxol) | 6.0mg/ml | >240 |
| Doxorubicin Hydrochloride(Adriamycin) | 2.0mg/ml | >240 |
| Dacarbazine | 10.0mg/ml | >240 |
| Cisplatin | 1.0mg/ml | >240 |
| Ifosfamide | 50.0mg/ml | >240 |
| Mitoxantrone | 2.0mg/ml | >240 |
| Vincristine Sulfate | 1.0mg/ml | >240 |
*Please note that following drugs have extremely low permeation times:
Carmustine (BCNU) :10.2 minutes and Thiotepa:40.5 minutes
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest
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)
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The minimum breakthrough detection times for various chemotherapy drugs are provided, ranging from 10.2 minutes (Carmustine (BCNU)) to >240 minutes for most other tested drugs.
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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2017
Careplus (M) Sdn. Bhd. Lim Shyan CEO/ Managing Director Lot 120 & 121, Jalan Senawang 3 Senawang Industrial Estate 70450 Seremban, Malaysia
Re: K162858
Trade/Device Name: Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: October 12, 2016 Received: June 26, 2017
Dear Lim Shyan:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mark S. Fellman -S
for
Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162858
Device Name
Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest
Indications for Use (Describe)
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.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drugs Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy | Concentration | Minimum Breakthrough Detection Time (min) |
|---|---|---|
| Fluorouracil (Adrucil) | 50.0mg/ml | >240 |
| Etopside(Toposar) | 20.0mg/ml | >240 |
| Cyclophosphamide(Cytoxan) | 20.0mg/ml | >240 |
| *Carmustine(BCNU) | 3.3mg/ml | 10.2 |
| *Thiotepa | 10.0mg/ml | 40.5 |
| Paclitaxel(Taxol) | 6.0mg/ml | >240 |
| Doxorubicin Hydrochloride(Adriamycin) | 2.0mg/ml | >240 |
| Dacarbazine | 10.0mg/ml | >240 |
| Cisplatin | 1.0mg/ml | >240 |
| Ifosfamide | 50.0mg/ml | >240 |
| Mitoxantrone | 2.0mg/ml | >240 |
| Vincristine Sulfate | 1.0mg/ml | >240 |
*Please note that following drugs have extremely low permeation times:
Carmustine (BCNU) :10.2 minutes and Thiotepa:40.5 minutes
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
[X] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.