(110 days)
Not Found
No
The device is a disposable medical examination glove and the description focuses on its material properties, testing against chemotherapy drugs, and compliance with ASTM standards. There is no mention of any computational or analytical functions that would involve AI or ML.
No.
The device is a disposable medical examination glove, which is used for contamination prevention between patients and examiners, not for treating any specific disease or condition.
No
Explanation: The device is described as disposable medical examination nitrile gloves, intended to be worn on an examiner's hand to prevent contamination. Its function is to provide a barrier, not to diagnose a condition or disease.
No
The device description clearly states it is a physical product, "Disposable Medical Nitrile Examination Gloves," made from a "nitrile compound." It is a tangible item worn on the hand.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection during medical examinations.
- Device Description: The device is described as a "patient examination glove made from nitrile compound." This further reinforces its function as a protective barrier.
- Lack of Diagnostic Function: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This glove does not perform any such diagnostic testing. Its purpose is purely protective.
- Testing with Chemotherapy Drugs: While the gloves were tested for resistance to chemotherapy drugs, this testing relates to the glove's barrier properties and safety for the user when handling these substances, not to a diagnostic function.
In summary, the device is a medical glove intended for protection, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
Disposable Medical Nitrile Examination Gloves (Non sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019):
The following drugs had NO breakthrough detected up to 240 minutes:
Busulfan, 6 mg/ml (6,000 ppm)
Carboplatin /Paraplatin, 10 mg/ml (10,000 ppm)
Cisplatin, 1.0 mg/ml (1,000 ppm)
Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000 ppm)
Cytarabine HCI, 100 mg/ml (100,000 ppm)
Dacarbazine, 10.0 mg/ml (10,000 ppm)
Docetaxel, 10 mg/ml (10,000 ppm)
Doxorubicin HCI, 2.0 mg/ml (2,000 ppm)
Etoposide, 20.0 mg/ml (20,000 ppm)
Fluorouracil, 50.0 mg/ml (50,000 ppm)
Ifosfamide, 50 mg/ml (50,000 ppm)
Mechlorethamine HCI, 1 mg/ml (1,000 ppm)
Methotrexate, 25 mg/ml (25,000 ppm)
Mitomycin, 0.5 mg/ml (500 ppm)
Mitoxantrone, 2 mg/ml (2,000 ppm)
Paclitaxel, 6.0 mg/ml (6,000 ppm)
Vincristine Sulfate, 1 mg/ml (1,000 ppm)
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes
ThioTepa10.0 mq/ml (10.000 ppm),35.7 minutes
WARNING: Do not use Carmustine and Thiotepa
Product codes (comma separated list FDA assigned to the subject device)
LZC, LZA
Device Description
The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile), a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and tested as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
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
examiner's hand
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)
Non-clinical testing summary includes:
- ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test: Determined width, length, and thickness of the gloves. Results for Small, Medium, and Large sizes passed their respective acceptance criteria for width, length, and thickness.
- ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test: Determined tensile strength and ultimate elongation before and after acceleration aging. Results showed that both tensile strength and ultimate elongation passed the minimum requirements (e.g., Before Aging: Tensile Strength Min 29 MPa, Ultimate Elongation Min 515%; After Aging: Tensile Strength Min 26 MPa, Ultimate Elongation Min 511%).
- ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves: To determine holes in the gloves. Result: Passed (AQL 2.5).
- ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves: To determine residual powder in the gloves. Result: 0.2 mg/glove, Passed (Acceptance Criteria:
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 8, 2021
Jiangsu Nanfang Medical Co., Ltd Johnson Liu Consultant CNMED Consultant 31 Archer St Upper MT Gravatt, QLD 4122 Australia
Re: K212639
Trade/Device Name: Disposable Medical Nitrile Examination Gloves (Non sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZC, LZA Dated: November 8, 2021 Received: November 12, 2021
Dear Johnson Liu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Clarence W. Murray III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212639
Device Name
Disposable Medical Nitrile Examination Gloves (Non Sterile)
Indications for Use (Describe)
Disposable Medical Examination Nitrile Gloves (Non Sterile) are disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019):
The following drugs had NO breakthrough detected up to 240 minutes:
| Busulfan,
6 mg/ml (6,000 ppm) | Fluorouracil,
50.0 mg/ml (50,000 ppm) |
|--------------------------------------------------------|---------------------------------------------|
| Carboplatin /Paraplatin,
10 mg/ml (10,000 ppm) | Ifosfamide,
50 mg/ml (50,000 ppm) |
| Cisplatin,
1.0 mg/ml (1,000 ppm) | Mechlorethamine HCI,
1 mg/ml (1,000 ppm) |
| Cyclophosphamide (Cytoxan),
20.0 mg/ml (20,000 ppm) | Methotrexate,
25 mg/ml (25,000 ppm) |
| Cytarabine HCI,
100 mg/ml (100,000 ppm) | Mitomycin,
0.5 mg/ml (500 ppm) |
| Dacarbazine,
10.0 mg/ml (10,000 ppm) | Mitoxantrone,
2 mg/ml (2,000 ppm) |
| Docetaxel,
10 mg/ml (10,000 ppm) | Paclitaxel,
6.0 mg/ml (6,000 ppm) |
| Doxorubicin HCI,
2.0 mg/ml (2,000 ppm) | Vincristine Sulfate,
1 mg/ml (1,000 ppm) |
| Etoposide,
20.0 mg/ml (20,000 ppm) | |
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes
ThioTepa10.0 mq/ml (10.000 ppm),35.7 minutes
WARNING: Do not use Carmustine and Thiotepa
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)
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Image /page/3/Picture/1 description: The image is a logo for Miao Shou. The logo is a green circle with a green flower inside. The flower has a hand in the center. The words "Miao Shou" are written in English and Chinese on either side of the flower.
510(K) Summary
Disposable Medical Nitrile Examination Gloves (Non sterile)
Preparation Date: November 8th, 2021
1. SUBMITTER
Company Name: Jiangsu Nanfang Medical Co.,Ltd Company Address: No.1 Guoxiang RD. Wujin Economic Development Zone, WUJIN CHANGZHOU Jiangsu, CN 213149
Contact Person: Johnson Liu Telephone Number: +614-0158-9995 Email: Johnson@cnmed.com.au
2. NAME OF THE DEVICE
Trade Name / Proprietary Name: Disposable Medical Nitrile Examination Gloves (Non sterile) Device Name: Disposable Medical Examination Nitrile Gloves Device Classification Name: Patient Examination Gloves Device Class: Class I Device Classification Number: 21 CFR 880.6250 Product Code: LZC LZA
3. IDENTIFICATION OF THE LEGALLY MARKETED DEVICE
Predicate Device: K172525 Applicant: Central Medicare Sdn. Bhd Device Name: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Device Classification Name: Patient Examination Gloves Device Classification Number: 21 CFR 880.6250 Device Class: Class I Product Code: LZC LZA Review Panel: General Hospital
4. DEVICE DESCRIPTION
The subject device in this 510(k) Notification is Disposable Medical Nitrile Examination Gloves (Non sterile), a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and tested as per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
4
Image /page/4/Picture/1 description: The image is a logo for a company called "Miao Shou". The logo is a green circle with a green flower in the center. The flower has a hand in the middle of it. The words "Miao Shou" are written in English and Chinese on either side of the flower. There is a registered trademark symbol in the upper right corner of the logo.
5. INDICATIONS for USE OF THE DEVICE
Disposable Medical Nitrile Examination Gloves (Non sterile) are a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
In addition, these patient examination gloves were tested for use with the following drug concentrations per ASTM D6978-05(2019):
The following drugs had NO breakthrough detected up to 240 minutes:
| Busulfan,
6 mg/ml (6,000 ppm) | Fluorouracil,
50.0 mg/ml (50,000 ppm) |
|--------------------------------------------------------|---------------------------------------------|
| Carboplatin /Paraplatin,
10 mg/ml (10,000 ppm) | Ifosfamide,
50 mg/ml (50,000 ppm) |
| Cisplatin,
1.0 mg/ml (1,000 ppm) | Mechlorethamine HCI,
1 mg/ml (1,000 ppm) |
| Cyclophosphamide (Cytoxan),
20.0 mg/ml (20,000 ppm) | Methotrexate,
25 mg/ml (25,000 ppm) |
| Cytarabine HCI,
100 mg/ml (100,000 ppm) | Mitomycin,
0.5 mg/ml (500 ppm) |
| Dacarbazine,
10.0 mg/ml (10,000 ppm) | Mitoxantrone,
2 mg/ml (2,000 ppm) |
| Docetaxel,
10 mg/ml (10,000 ppm) | Paclitaxel,
6.0 mg/ml (6,000 ppm) |
| Doxorubicin HCI,
2.0 mg/ml (2,000 ppm) | Vincristine Sulfate,
1 mg/ml (1,000 ppm) |
| Etoposide,
20.0 mg/ml (20,000 ppm) | |
Please note that the following drug has low permeation times of less than 60 minutes:
Carmustine (BCNU) 3.3 mg/ml (3,300 ppm), 44.7minutes
ThioTepa10.0 mg/ml (10,000 ppm),35.7 minutes
WARNING: Do not use Carmustine and Thiotepa
5
6. TECHNOLOGICAL CHARACTERISTIC COMPARISON FOR THE PROPOSED AND PREDICATE DEVICES
| DEVICE PERFORMANCE | ||||
|---|---|---|---|---|
| CHARACTERISTICS | SUBJECT | PREDICATE | REMARKS | |
| 510(k) Number | K212639 | K172525 | - | |
| Device Name | Disposable Medical Nitrile | |||
| Examination Gloves (Non sterile) | Blue Non Sterile Powder Free | |||
| Nitrile Examination Gloves | ||||
| Tested for Use with | ||||
| Chemotherapy Drugs | - | |||
| Product Code | LZC LZA | LZC LZA | Same | |
| Indications for Use | Disposable Medical Nitrile | |||
| Examination Gloves (Non sterile) are | ||||
| a disposable device intended for | ||||
| medical purposes that is worn on the | ||||
| examiner's hand to prevent | ||||
| contamination between patient and | ||||
| examiner. | Blue Non Sterile Powder Free | |||
| Nitrile Examination Gloves | ||||
| Tested for Use with | ||||
| Chemotherapy Drugs is a | ||||
| disposable device intended for | ||||
| medical purposes that is worn | ||||
| onthe examiner's hands to | ||||
| prevent contamination between | ||||
| patient and examiner. | Same | |||
| Chemotherapy Drugs Permeation | ||||
| Claim | Busulfan, Carboplatin /Paraplatin, | |||
| Cisplatin, Cyclophosphamide | ||||
| (Cytoxan), Cytarabine HCI, | ||||
| Dacarbazine, Docetaxel, Doxorubicin | ||||
| HCI, Etoposide, Fluorouracil, | ||||
| Ifosfamide, Mechlorethamine HCI, | ||||
| Methotrexate, Mitomycin, | ||||
| Mitoxantrone, Paclitaxel, Vincristine | ||||
| Sulfate. | Fluorouracil, Etoposide | |||
| (Toposar), Cyclophosphamid | ||||
| (Cytoxan), Carmustine | ||||
| (BCNU), Thiotepa, Paclitaxel | ||||
| (Taxol), Doxorubicin | ||||
| Hydrochloride, Dacarbazine | ||||
| (DTIC), Cisplatin, | ||||
| Ifosfamide, Mitoxantrone, | ||||
| Vincristine Sulfate | Equivalent | |||
| Materials of Use | ||||
| (ASTM | ||||
| D6910/D6910M-19) | Nitrile compound | Nitrile compound | Same | |
| Color | Blue | Blue | Same | |
| Texture | Finger Textured | Finger Textured | Same | |
| Size | ||||
| (ASTM D6319-19) | Small, Medium, Large, | Small, Medium, Large, | ||
| Extra Large | Same | |||
| Sterilization | Non-sterile | Non-sterile | Same | |
| Usage | Single usage | Single usage | Same | |
| Dimensions | ||||
| (ASTM D6319-19) | Length Min. 220 min Width Min | |||
| 80+/-10 mm (for small size) | ||||
| Length Min. 230 min Width Min | ||||
| 95+/-10 mm (for medium size) | ||||
| Length Min. 230 min Width Min | ||||
| 110+/-10 mm (for large size) | Length Min. 230 min Width Min | |||
| 80+/-10 mm (for small size) | ||||
| Length Min. 230 min Width Min | ||||
| 95+/-10 mm (for medium size) | ||||
| Length Min. 230 min Width Min | ||||
| 110+/-10 mm (for large size) | Equivalent | |||
| Physical Properties | ||||
| (ASTM D6319-19) | Before Aging | |||
| Tensile Strength | ||||
| Min 14 Mpa Ultimate Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| Min 14 Mpa Ultimate Elongation | ||||
| Min 400% | Same | |||
| Thickness | ||||
| (ASTM D6319-19) | Palm min 0.05 mm | Palm min 0.08 mm | Equivalent | |
| Finger min 0.05 mm | Finger min 0.10 mm | |||
| Powder Free | ||||
| (ASTM D6319-19) |