(209 days)
Not Found
Not Found
No
The summary describes a standard medical examination glove and does not mention any AI or ML capabilities.
No
The device is a medical glove, which is a barrier device used to prevent contamination, not to treat a health condition or disease.
No
Explanation: The device is a patient examination glove, described as a disposable device for preventing contamination between patient and examiner. Its intended use is not for diagnosing medical conditions.
No
The device description clearly states it is a "Powder-Free Nitrile Examination Glove," which is a physical hardware device. The summary focuses on the physical properties and testing of the 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 the device is a "patient examination glove" worn on the hand or finger to prevent contamination between patient and examiner. This is a physical barrier device used during patient examination.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This glove does not perform such an examination.
- Device Description: The description confirms it's a glove, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests. The testing mentioned (ASTM D6978-05) is for the glove's barrier properties against chemotherapy drugs, not for diagnosing a condition.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
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 chemotheraov drues as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This device is single use only.
WARNING: Do not use with Carmustine and Thiotepa.
Product codes (comma separated list FDA assigned to the subject device)
LZC, LZA
Device Description
Powder-Free Nitrile Examination Glove with pH coating, Black-Gray Color, Tested for Use with Chemotherapy Drugs. A patient examination glove is a disposable device intended for medical purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger (worn on the examiner's hand or finger)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Medical 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
Tested for use with chemotheraov drues as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Breakthrough Detection Time in Minutes |
|---|
- Carmustine (BCNU), 3.3mg/ml | 27.1
- Cisplatin, 1.0mg/ml | >240
- Cyclophosphamide (Cytoxan), 20mg/ml | >240
- Dacarbazine (DTIC) 10mg/ml | >240
- Doxorubicin Hydrochloride, 2.0 mg/ml | >240
- Etoposide (Toposar), 20mg/ml | >240
- Fluorouracil 50mg/ml | >240
- Paclitaxel (Taxol), 6.0mg/ml | >240
- Thiotepa, 10mg/ml | 27.4
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Breakthrough detection times in minutes were reported for 9 different chemotherapy drugs with varying concentrations. Carmustine (BCNU) had a breakthrough time of 27.1 minutes, and Thiotepa had a breakthrough time of 27.4 minutes. The remaining 7 drugs had breakthrough times greater than 240 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Breakthrough Detection Time in Minutes for various chemotherapy drugs.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 8, 2018
Shen Wei USA Inc. Cheryl Reep Compliance Director 33278 Central Ave Ste 102 Union City, California 94587
Re: K173766
Trade/Device Name: PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC, LZA Dated: June 19, 2018 Received: July 3, 2018
Dear Cheryl Reep:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Elizabeth F. Claverie -S
For Tina Kiang, Ph.D. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K173766
Device Name
Powder-Free Nitrile Examination Glove with pH coating, Black-Gray Color, Tested for Use with Chemotherapy Drugs
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 chemotheraov drues as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. This device is single use only.
| Chemotherapy Drug and Concentration | Breakthrough Detection Time in Minutes |
|---|---|
| 1. Carmustine (BCNU), 3.3mg/ml | 27.1 |
| 2. Cisplatin, 1.0mg/ml | >240 |
| 3. Cyclophosphamide (Cytoxan), 20mg/ml | >240 |
| 4. Dacarbazine (DTIC) 10mg/ml | >240 |
| 5. Doxorubicin Hydrochloride, 2.0 mg/ml | >240 |
| 6. Etoposide (Toposar), 20mg/ml | >240 |
| 7. Fluorouracil 50mg/ml | >240 |
| 8. Paclitaxel (Taxol), 6.0mg/ml | >240 |
| 9. Thiotepa, 10mg/ml | 27.4 |
*Please note that Carmustine (BCNU) has low permeation time of 27.1 minutes and Thiotepa has permeation time of 27.4 minutes.
WARNING: Do not use with Carmustine and Thiotepa.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.