(105 days)
No
The device is a disposable examination glove and the description focuses on material properties and testing standards, with no mention of AI or ML.
No.
The device is a glove intended to prevent contamination between a patient and an examiner; it does not directly treat or diagnose a medical condition.
No
Explanation: The device is a disposable examination glove intended for medical purposes to prevent contamination, not to diagnose any condition or disease.
No
The device is a physical examination glove, not a software product. The description clearly details a tangible item made of nitrile.
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 for personal protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description reinforces that it's a "disposable examination glove intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner."
- Testing: While the gloves are tested for permeation by chemotherapy drugs and Fentanyl, this testing is related to the protective barrier function of the glove, not to the analysis of biological specimens.
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), performing any kind of analysis on these samples, or providing diagnostic information.
Therefore, the Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl is a medical device, but it falls under the category of a protective barrier device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl 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.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
The tested chemotherapy drugs are:
Bleomycin sulfate (15.0 mg/ml 15,000 ppm) >240 min
Carboplatin (10.0 mg/ml 10,000 ppm) >240 min
Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 13.2
Cisplatin (1.0 mg/mL 1,000 ppm) >240 min
Cyclophosphamide (20.0 mg/mL 20,000 ppm) >240 min
Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) >240 min
Dacarbazine (10.0 mg/mL 10.000 ppm) >240 min
Doxorubicin HCL (2.0 mg/mL 2,000 ppm) >240 min
Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min
Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min
Idarubicin (1.0 mg/ml 1.000 ppm) >240 min
Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min
Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) >240 min
Methotrexate (25.0 mg/mL 25,000 ppm) >240 min
Mitomycin C (0.5 mg/mL 500 ppm) >240 min
Mitoxantrone HCL (2.0 mg/mL 2.000 ppm >240 min
Paclitaxel (6.0 mg/mL 6.000 ppm) >240 min
Thiotepa (10.0 mg/mL 10,000 ppm) 13.1
Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min
The tested non-chemotherapy drugs are:
Fentanyl Citrate Injection (100 mcg/2mL) >240 min
MESNA (100.0 mg/mL 100,000 ppm) >240 min
Trisenox (1.0 mg/ml 1,000 ppm) >240 min
Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively.
Warning: Do Not Use with Carmustine, Thiotepa
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, QDO
Device Description
The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in six sizes, extra small, small, medium, large, extra-large and extra extra-large, packed in a paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand or finger (worn on examiner's)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A Biocompatibility
Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the subject device is Surface and External Communicating Device category and duration of contact is A-Limited (=14 MPa, min. After Aging >=14 MPa, min.
- Elongation: Before Aging 500%, min. After Aging 400%, min.
- Freedom from holes: No leakage at sampling level of G-1, AQL 2.5.
- Residual Powder: 240 minutes for most tested substances.
Predicate Device(s)
Reference Device(s)
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 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.
April 1, 2024
Shandong Xingyu Gloves Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K233990
Trade/Device Name: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: March 11, 2024 Received: March 11, 2024
Dear Ivy Wang:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Allan G
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control
2
and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233990
Device Name
Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000)
Indications for Use (Describe)
The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl 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.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05.
The tested chemotherapy drugs are:
Chemotherapy drug Concentration Minimum Breakthrough Detection Time
Bleomycin sulfate (15.0 mg/ml 15,000 ppm) >240 min
Carboplatin (10.0 mg/ml 10,000 ppm) >240 min
Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 13.2
Cisplatin (1.0 mg/mL 1,000 ppm) >240 min
Cyclophosphamide (20.0 mg/mL 20,000 ppm) >240 min
Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) >240 min
Dacarbazine (10.0 mg/mL 10.000 ppm) >240 min
Doxorubicin HCL (2.0 mg/mL 2,000 ppm) >240 min
Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min
Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min
Idarubicin (1.0 mg/ml 1.000 ppm) >240 min
Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min
Mechlorethamine HCL (1.0 mg/ml 1,000 ppm) >240 min
Methotrexate (25.0 mg/mL 25,000 ppm) >240 min
Mitomycin C (0.5 mg/mL 500 ppm) >240 min
Mitoxantrone HCL (2.0 mg/mL 2.000 ppm >240 min
Paclitaxel (6.0 mg/mL 6.000 ppm) >240 min
Thiotepa (10.0 mg/mL 10,000 ppm) 13.1
Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min
The tested non-chemotherapy drugs are:
Fentanyl Citrate Injection (100 mcg/2mL) >240 min
MESNA (100.0 mg/mL 100,000 ppm) >240 min
Trisenox (1.0 mg/ml 1,000 ppm) >240 min
Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively.
Warning: Do Not Use with Carmustine, 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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."
5
510(K) Summary
K233990
(As required by 21 CFR 807.92)
Date prepared: 2024-04-01
A. Applicant:
Name: Shandong Xingyu Gloves Co., Ltd. Address: NO. 2158 Yaoqian Road, Economic Development Zone, Gaomi City, Shandong Province, China Contact: Ms. Carrie Lee Title: QA Manager Tel: 0086-536-2580359 Email: carrie@xingyugloves.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com
B. Device:
Trade Name: Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Common Name: Nitrile Patient Examination Gloves (Powder Free) Model: D5000 Size(s): XS, S, M, L, XL, XXL
Regulatory Information Classification Name: Polymer Patient Examination Glove Classification: Class I Product code: LZA (Primary), LZC, OPJ, QDO Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
C. Predicate device:
510K Number: K223903 Trade Name: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl Manufacturer: SEMPERIT INVESTMENTS ASIA PTE. LTD. Reference Device
6
510K Number: K212735
Trade Name: Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) Manufacturer: Xingyu Medical Tech Co., Ltd.
D. Indications for use of the device:
The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl 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.
Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978-05. The tested chemotherapy drugs are:
| Chemotherapy drug | Concentration | Minimum Breakthrough Detection Time |
|---|---|---|
| Bleomycin sulfate | (15.0 mg/ml 15,000 ppm) | >240 min |
| Carboplatin | (10.0 mg/ml 10,000 ppm) | >240 min |
| Carmustine (BCNU) | (3.3mg/mL 3,300 ppm) | 13.2 |
| Cisplatin | (1.0 mg/mL 1,000 ppm) | >240 min |
| Cyclophosphamide | (20.0 mg/mL 20,000 ppm) | >240 min |
| Cytarabine (Cytosine) | (100.0 mg/mL 100,000 ppm) | >240 min |
| Dacarbazine | (10.0 mg/mL 10,000 ppm) | >240 min |
| Doxorubicin HCL | (2.0 mg/mL 2,000 ppm) | >240 min |
| Etoposide (Toposar) | (20.0 mg/mL 20,000 ppm) | >240 min |
| Fluorouracil (5 Flu) | (50.0 mg/mL 50,000 ppm) | >240 min |
| Idarubicin | (1.0 mg/ml 1,000 ppm) | >240 min |
| Ifosfamide | (50.0 mg/mL 50,000 ppm) | >240 min |
| Mechlorethamine HCL | (1.0 mg/ml 1,000 ppm) | >240 min |
| Methotrexate | (25.0 mg/mL 25,000 ppm) | >240 min |
| Mitomycin C | (0.5 mg/mL 500 ppm) | >240 min |
| Mitoxantrone HCL | (2.0 mg/mL 2,000 ppm | >240 min |
| Paclitaxel | (6.0 mg/mL 6,000 ppm) | >240 min |
| Thiotepa | (10.0 mg/mL 10,000 ppm) | 13.1 |
| Vincristine Sulfate | (1.0 mg/mL 1,000 ppm | >240 min |
| The tested non-chemotherapy drugs are: | ||
| Fentanyl Citrate Injection | (100 mcg/2mL) | >240 min |
| MESNA | (100.0 mg/mL 100,000 ppm) | >240 min |
Note: Carmustine and Thiotepa have extremely low permeation times of 13.2 and 13.1 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa
240 min
(1.0 mg/ml 1,000 ppm)
E. Device Description:
Trisenox
The Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in six sizes, extra small, small, medium, large, extra-large and extra extra-large, packed in a paper box.
7
The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
F. Summary of Technological Characteristics
Table 1 General Comparison of Proposed and Predicate Devices
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K233990 | K223903 | - |
| Product Name | Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) | Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl | - |
| Product Code | LZA (primary), LZC, OPJ, QDO | LZA (primary), LZC, OPJ, QDO | Same |
| Classification | Class I | Class I | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for use | The Nitrile Disposable Examination Glove, Tested for Use with Chemotherapy Drugs and Fentanyl is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | ||
| Gloves have been tested for use with chemotherapy drugs and Fentanyl Citrate using ASTM D6978. | |||
| The tested chemotherapy drugs are: | |||
| Chemotherapy drug Concentration | |||
| Minimum Breakthrough Detection Time | |||
| Bleomycin sulfate (15.0 mg/ml 15,000 ppm) >240 min | |||
| Carboplatin (10.0 mg/ml 10,000 ppm) > 240 min | |||
| Carmustine (BCNU) (3.3mg/mL 3,300 ppm) 13.2 | |||
| Cisplatin (1.0 mg/mL 1,000 ppm) >240 min | |||
| Cyclophosphamide (20.0 mg/mL 20,000 ppm) >240 min | |||
| Cytarabine (Cytosine) (100.0 mg/mL 100,000 ppm) >240 min | |||
| Dacarbazine (10.0 mg/mL 10,000 ppm) >240 min | |||
| Doxorubicin HCl (2.0 mg/mL 2,000 | This device is an ambidextrous patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between patient and examiner. | ||
| The tested chemotherapy drugs are: Carmustine (BCNU) (3.3 mg/ml). Permeation time: Carmustine (BCNU) has extremely low permeation times of 14.7 minutes. | |||
| Cisplatin (1.0 mg/ml). Permeation time: no breakthrough up to 240 minutes | |||
| Cyclophosphamide (Cytoxan) (20.0 mg/ml). Permeation time: no breakthrough up to 240 minutes | |||
| Cytarabine (100 mg/ml). Permeation time: no breakthrough up to 240 minutes Dacarbazine (DTIC) (10.0 mg/ml). Permeation time: no breakthrough up to 240 minutes | |||
| Doxorubicin Hydrochloride (2.0 mg/ml). Permeation time: no breakthrough un | Similar | ||
| The proposed device and the predicate device have same indications, only minor differences on different drugs and the penetration time of carmustine and thiotepa between the proposed device and the predicate device, which will not raise any new safety or performance | |||
| > 240 min | to 240 minutes | concerns. | |
| Etoposide (Toposar) (20.0 mg/mL | |||
| 20,000 ppm) > 240 min | Etoposide (20.0 mg/ml). Permeation | ||
| time: no breakthrough up to 240 | |||
| minutes | |||
| Fluorouracil (5 Flu) (50.0 mg/mL | |||
| 50,000 ppm) >240 min | Fluorouracil (50.0 mg/ml). | ||
| Permeation time: no breakthrough up | |||
| to 240 minutes | |||
| Idarubicin (1.0 mg/ml 1,000 ppm) > | |||
| 240 min | |||
| Ifosfamide (50.0 mg/mL 50,000 ppm) |
240 min | Ifosfamide (50.0 mg/ml). Permeation
time: no breakthrough up to 240
minutes | |
| | Mechlorethamine HCL (1.0 mg/ml 1,000
ppm) > 240 min | Methotrexate (25.0
mg/ml). Permeation time: no
breakthrough up to 240 minutes | |
| | MESNA (100.0 mg/mL 100,000 ppm) >
240 min | | |
| | Methotrexate (25.0 mg/mL 25,000
ppm) >240 min | Mitomycin C (0.5 mg/ml). Permeation
time: no breakthrough up to 240
minutes | |
| | Mitomycin C (0.5 mg/mL 500 ppm) >
240 min | | |
| | Mitoxantrone HCL (2.0 mg/mL 2,000 ppm
240 min | Mitoxantrone (2.0 mg/ml).
Permeation time: no breakthrough up
to 240 minutes | |
| | Paclitaxel (6.0 mg/mL 6,000 ppm) >
240 min | Paclitaxel (Taxol) (6.0
mg/ml). Permeation time: no
breakthrough up to 240 minutes | |
| | Thiotepa (10.0 mg/mL 10,000 ppm)
13.1 | Thiotepa (10.0 mg/ml). Permeation
time: Thiotepa has extremely low
permeation times of 13.6 minutes | |
| | Trisenox (1.0 mg/ml 1,000 ppm) > 240
min | Vincristine Sulfate (1.0 mg/ml).
Permeation time: no Breakthrough up
to 240 minutes. | |
| | Vincristine Sulfate (1.0 mg/mL 1,000 ppm
240 min | | |
| | Fentanyl Citrate Injection (100 mcg/2mL) >
240 min | The tested Opioid is:
Fentanyl Citrate Injection
(100mcg/2mL). Permeation: no
breakthrough up to 240 minutes | |
| | Note: Carmustine and Thiotepa have
extremely low permeation times of 13.2
and 13.1 minutes respectively. | Please note that the following drugs
have extremely low permeation times:
Carmustine: 14.7 minutes
Thiotepa: 13.6 minutes
Warning: DO NOT USE WITH
CARMUSTINE OR THIOTEPA | |
| Powder free | Yes | Yes | Same |
| Design
feature | Ambidextrous | Ambidextrous | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Singe use | Single use | Same |
| Labeling claim | Tested for Use with Chemotherapy Drugs
and Fentanyl | Tested for Use with Chemotherapy Drugs
and Fentanyl | Same |
8
9
Table 2 Device dimension comparison
| Technological characteristics | Proposed
Device
(K233990) | Predicate
Device
(K223903) | Device | Result |
|-------------------------------|---------------------------------|----------------------------------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Length | | | | |
| XS, S | Minimum 240mm | Minimum 220mm | | Different |
| M, L, XL | | Minimum 230mm | | The length dimension of the |
| XXL | | Not available | | proposed device is not the
same with the predicate
device, while both are meet
the criteria of the ASTM
D6319 standard. |
| Palm width (size) (mm) | | | | |
| XS | 70±10 | 70±10 | | Same |
| S | 80±10 | 80±10 | | Same |
| M | 95±10 | 95±10 | | Same |
| L | 110±10 | 110±10 | | same |
| XL | 120±10 | 120±10 | | Same |
| XXL | 130±10 | Not available | | Different
The proposed device has one
more size (XXL) than the
predicate device, however
the dimension of the
proposed device has been
tested and complied with the
ASTM D6319-19. This
dimension different will not
raise any new safety or
performance concerns. |
| Thickness (mm) | | | | |
| Finger | ≥0.05 | ≥0.05 | | Same |
| Palm | ≥0.05 | ≥0.05 | | Same |
Table 3 Performance comparison
| Item | | Proposed device
(K233990) | Predicate
(K223903) | device | Result |
|------------------------|--------------|------------------------------|------------------------|------------|--------|
| Physical
properties | Before aging | Tensile strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate elongation | 500%, min | 500%, min | Same |
| | After aging | Tensile strength | 14MPa, min | 14MPa, min | Same |
10
| Ultimate elongation | 400%, min | 400%, min | Same | |
|---|---|---|---|---|
| Comply with ASTM D6319 | Comply with ASTM D6319 | Same | ||
| Freedom from holes | Be free from holes when tested in accordance with ASTM D5151 G-1, AQL 2.5 | Be free from holes when tested in accordance with ASTM D5151 G-1, AQL 2.5 | Same | |
| Residual Powder | Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Same |
Table 4 Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drugs, non-chemotherapy drugs and fentanyl and Concentration | Minimum breakthrough detection time in minutes | Result | ||
|---|---|---|---|---|
| Proposed device (K233990) | Predicate device (K223903) | Reference device (K212735) | ||
| Bleomycin sulfate (15.0 mg/ml 15,000 ppm) | >240 | Not available | >240 | Same with reference device |
| Carboplatin (10.0 mg/ml 10,000 ppm) | >240 | Not available | >240 | Same with reference device |
| Carmustine (BCNU) (3.3mg/mL 3,300 ppm) | 13.2 | 14.7 | 47.9 | Similar |
| Cisplatin (1.0 mg/mL 1,000 ppm) | >240 | >240 | >240 | Same |
| Cyclophosphamide (20 mg/mL 20,000 ppm) | >240 | >240 | >240 | Same |
| Cytarabine (Cytosine) (100 mg/mL 100,000 ppm) | >240 | >240 | >240 | Same |
| Dacarbazine (10 mg/mL 10,000 ppm) | >240 | >240 | >240 | Same |
| Doxorubicin HCL (2.0 mg/mL 2,000 ppm) | >240 | >240 | >240 | Same |
| Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) | >240 | >240 | >240 | Same |
| Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) | >240 | >240 | >240 | Same |
| Idarubicin (1.0 mg/ml 1,000 ppm) | >240 | Not available | >240 | Same with reference device |
| Ifosfamide (50.0 mg/mL 50,000 ppm) | >240 | >240 | >240 | Same |
| Mechlorethamine HCI | >240 | Not available | >240 | Same with |
11
| (1.0 mg/ml 1,000 ppm) | reference | |||
|---|---|---|---|---|
| device | ||||
| MESNA (100.0 mg/mL 100,000 ppm) | >240 | Not available | >240 | Same with |
| reference | ||||
| device | ||||
| Methotrexate (25.0 mg/mL 25,000 ppm) | >240 | >240 | >240 | Same |
| Mitomycin C (0.5 mg/mL 500 ppm) | >240 | >240 | >240 | Same |
| Mitoxantrone HCL (2.0 mg/mL 2,000 ppm | >240 | >240 | >240 | Same |
| Paclitaxel (6.0 mg/mL 6,000 ppm) | >240 | >240 | >240 | Same |
| Thiotepa (10.0 mg/mL 10,000 ppm) | 13.1 | 13.6 | >240 | Similar |
| Trisenox (1.0 mg/ml 1,000 ppm) | >240 | Not available | >240 | Same with |
| reference | ||||
| device | ||||
| Vincristine Sulfate (1.0 mg/mL 1,000 ppm | >240 | >240 | >240 | Same |
| Fentanyl Citrate Injection (100 mcg/2mL) | >240 | >240 | Not applicable | Same |
Similar Analysis:
Minor differences on the penetration time of carmustine and thiotepa between the proposed device and the predicate device, which will not raise any new safety or performance concerns.
Table 5 Biocompatibility comparison
| Item | | Proposed device
(K233990) | Predicate device
(K223903) | Result |
|------------------|--------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------|----------------------------------------------------------------------------------------------------|
| Material | | Nitrile | Nitrile | Same |
| Biocompatibility | Irritation
ISO 10993-23 | Under the
conditions of the
study, not an
irritant. | Comply with ISO
10993-10 | Same |
| | Sensitization
ISO 10993-10 | Under the
conditions of the
study, not a
sensitizer. | | |
| | Acute Systemic
Toxicity
ISO 10993-11 | Under the
conditions of the
study, the device
extract does not
induce acute | Not available | Different
Acute systemic
toxicity information
for the predicate
device is not publicly |
12
| | systemic toxicity | | available. This does
not raise different |
|--|-------------------|--|------------------------------------------------------------------------------------------------------------------------------------|
| | response. | | safety or
performance |
| | | | questions since the
subject device has
acceptable
biocompatibility per
the biocompatibility
endpoint
assessment. |
G. Summary of Non-Clinical Testing
A Biocompatibility
Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the subject device is Surface and External Communicating Device category and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to evaluate the biocompatibility of Nitrile Disposable Examination Gloves as per Guidance for Industry and FDA Staff -Medical Glove Guidance Manual issued on January 22, 2008:
- ISO 10993-23: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- · ISO 10993-11: Acute Systemic Toxicity
A Performance Testing
Physical performance testing of the proposed device was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124-06 (2022) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Dimensions (width) | |||
| (thickness) | |||
| ASTM D6319-19 | The purpose of the test is to | ||
| evaluate the physical | |||
| dimension of the glove | Length | ||
| 240mm min | Pass | ||
| Width | |||
| S: 80±10mm | |||
| M: 95±10mm | |||
| L: 110±10mm | |||
| XL: 120 ± 10mm |
13
| XXL: 130±10mm | |||
|---|---|---|---|
| Palm - 0.05mm min. | Pass | ||
| Finger - 0.05mm min. | |||
| Physical properties | |||
| ASTM D6319-19 | The purpose of the test is to | ||
| evaluate the tensile strength | |||
| and ultimate elongation | |||
| before and after aging | Tensile Strength: | ||
| Before Aging ≥14 MPa, min. | |||
| After Aging ≥14 MPa, min. | |||
| Elongation: | |||
| Before Aging 500%, min. | |||
| After Aging 400%, min. | Pass | ||
| Freedom from holes | |||
| ASTM D5151-19 | The purpose of the test is to | ||
| detect holes in the gloves | No leakage at sampling level of G-1, | ||
| AQL 2.5 | Pass | ||
| Residual Powder | |||
| ASTM D6124-06 | |||
| (2022) | The purpose of the test is to | ||
| detect the powder residue in | |||
| the glove |