(52 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of examination gloves, with no mention of AI or ML technologies.
No
The device is described as an examination glove intended to prevent contamination between patient and examiner, not to treat or cure a disease or condition.
No
The device is a glove intended to prevent contamination between patient and examiner, and its description focuses on its material properties and barrier function, not on diagnosing medical conditions.
No
The device description clearly identifies the device as "Powder Free Nitrile Examination Gloves," which are physical, disposable gloves. The summary focuses on material properties, physical dimensions, and resistance to chemicals, all indicative of a hardware device. There is no mention of software components or functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body.
- Device Function: The description clearly states the glove is a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." Its primary function is a barrier to prevent the spread of contamination.
- Lack of Diagnostic Purpose: The glove does not analyze any biological samples or provide any diagnostic information about a patient's health. Its purpose is purely protective.
- Testing Focus: The testing described focuses on the glove's physical properties, barrier function (water leak, drug permeation), and biocompatibility, not on its ability to diagnose or detect a medical condition.
The testing for chemotherapy drugs and Fentanyl Citrate is related to the glove's ability to act as a barrier against these substances, which is a safety feature for the user, not a diagnostic function.
N/A
Intended Use / Indications for Use
The glove 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, Fentanyl Citrate, and select other drugs using ASTM D6978-05(2019)
The following chemicals have been tested with these gloves:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine 3.3 mg/ml (3,300 ppm) | 29.1 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel , 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine Phosphate, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine HCL, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan HCL, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan HCL, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 78.3 |
| Topotecan HCL, 1mg/ml (1,000ppm) | >240 |
| Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
Fentanyl Citrate & other drugs
| Fentanyl Citrate Injection, 100mcg/2mg | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
*Please note that the following drugs have extremely low permeation times: Carmustine: 29.1 minutes, Thiotepa: 78.3 minutes Warning: Do not use with Carmustine and Thiotepa.
Product codes
LZA, LZC, ODQ, OPJ
Device Description
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical Dimensions Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL, XXL | Pass |
| ASTM D6319- 19 | Physical Dimensions Thickness | Finger: 0.05mm (min) Palm: 0.05mm (min) | Pass |
| ASTM D6319- 19 ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14 MPa) and Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319- 19 ASTM D5151-19 | Water leak test | G-I, AQL 2.5 | Pass |
| ASTM D6319- 19 ASTM D6124-06(2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05(2019) | Chemotherapy Drugs, Opioid Drug Permeation | Refer the above tables | Pass |
| ISO 10993-10&-23 | Irritation and Skin Sensitization | Skin sensitization and Skin irritation | non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | showed potential toxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of acute systemic toxicity. |
No clinical testing was submitted for the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
February 29, 2024
Lingshi Hongruida Health Protection Technology Co., Ltd. Tinglong Chai General Manager Yangjiayuan, Liangdu Town, Lingshi County Jinzhong, Shanxi 031300 China
Re: K240051
Trade/Device Name: Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and select other drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, ODQ, OPJ Dated: January 6, 2024 Received: January 8, 2024
Dear Tinglong Chai:
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 (OS) 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 Guan -S
For Bifeng Qian, M.D., Ph.D. Assistant Director
2
DHT4B: Division of Infection Control 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) K240051
Device Name
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs
Indications for Use (Describe)
The glove 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, Fentanyl Citrate, and select other drugs using ASTM D6978-05(2019)
The following chemicals have been tested with these gloves:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine 3.3 mg/ml (3,300 ppm) | 29.1 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel , 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine Phosphate, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine HCL, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan HCL, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan HCL, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 78.3 |
| Topotecan HCL, 1mg/ml (1,000ppm) | >240 |
| Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
Fentanyl Citrate & other drugs Fentanyl Citrate Injection, 100mcg/2mg
FORM FDA 3881 (6/20)
Minimum Breakthrough Detection Time in Minutes
240
4
| Chloroquine 50mg/ml (50,000ppm) | >240 |
|---|---|
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
*Please note that the following drugs have extremely low permeation times: Carmustine: 29.1 minutes, Thiotepa: 78.3 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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5
The assigned 510(K) numbers: K240051
Date Prepared: February 29, 2024
1. Owner's Identification:
Lingshi Hongruida Health Protection Technology Co., Ltd. Yangjiayuan. Liangdu Town, Lingshi County, Jinzhong City, Shanxi Province, 031300. China Tel:86-311-66179668 Contact: Mr. Chai Tinglong, General Manager Email: janicema(@hongrayusa.com or fdareg(@hongray.com.cn
2. Name of the Device:
Trade / Product Name: Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs Common Name: Exam Gloves Classification Name: Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, QDO, OPJ Classification Panel: General Hospital Device Class: Class I
3. Predicate Device Information:
Lingshi Hongruida Health Protection Technology Co., Ltd. Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentany) Citrate (K223320)
4. Device Description:
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and select other drugs are Class I Patient Examination Gloves and Specialty Chemotherapy Gloves. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs, Fentanyl Citrate, and select other drugs as per ASTM D6978-05(2019). The gloves are single use, disposable, and non-sterile.
5. Device Modification
The proposed modification to the predicate device is adding additional Chemotherapy drugs. We have tested the proposed device (exactly same as predicate device) for use with chemotherapy drugs as per ASTM D6978 and gotten the testing report to support this claim. Please note that there are no differences with these two gloves from materials, manufacturing process and bench performance.
6. Indications for Use:
The glove 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, Fentanyl Citrate, and select other drugs using ASTM D6978-05(2019)
The following chemicals have been tested with these gloves:
| Chemotherapy Drug | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 |
| Busulfan 6mg/ml (6,000 ppm) | >240 |
| Carboplatin 10mg/ml (10,000 ppm) | >240 |
| Carmustine 3.3 mg/ml (3,300 ppm) | 29.1 |
| Cisplatin 1mg/ml (1,000 ppm) | >240 |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 |
| Cytarabine, 100 mg/ml (100,000 ppm) | >240 |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 |
| Docetaxel , 10 mg/ml (10,000 ppm) | >240 |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 |
| Fludarabine Phosphate, 25 mg/ml (25,000 ppm) | >240 |
| Fluorouracil, 50mg/ml (50,000ppm) | >240 |
| Gemcitabine HCL, 38mg/ml (38,000ppm) | >240 |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 |
| Irinotecan HCL, 20mg/ml (20,000ppm) | >240 |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 |
| Melphalan HCL, 5mg/ml (5,000ppm) | >240 |
| Methotrexate, 25mg/ml (25,000ppm) | >240 |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 |
| Paraplatin, 10mg/ml (10,000ppm) | >240 |
| Rituximab, 10mg/ml (10,000ppm) | >240 |
| Thiotepa, 10mg/ml (10,000ppm) | 78.3 |
| Topotecan HCL, 1mg/ml (1,000ppm) | >240 |
| Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) | >240 |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 |
| Fentanyl Citrate & other drugs | Minimum Breakthrough Detection Time in Minutes |
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 |
| Chloroquine 50mg/ml (50,000ppm) | >240 |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 |
| Retrovir, 10mg/ml (10,000ppm) | >240 |
6
*Please note that the following drugs have extremely low permeation times: Carmustine: 29.1 minutes, Thiotepa: 78.3 minutes Warning: Do not use with Carmustine and Thiotepa.
7. Comparison of Subject Device and Predicate Device:
7
General Comparison Table:
| Proposed Device | Predicate Device | Result of | |
|---|---|---|---|
| comparison | |||
| K240051 | K223320 | ||
| Trade Name | Powder Free Nitrile Examination | ||
| Gloves (Blue), Tested for Use with | |||
| Chemotherapy Drugs. Fentanyl | |||
| Citrate, and select other drugs | Powder Free Nitrile Examination | ||
| Gloves (Blue), Tested for Use with | |||
| Chemotherapy Drugs and Fentanyl | |||
| Citrate | Same | ||
| Product Code | LZA, LZC, QDO, OPJ | LZA, LZC, QDO | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Class | I | I | Same |
| Indications for Use | The glove 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, Fentanyl Citrate, and select | |||
| other drugs using ASTM D6978- | |||
| 05(2019) | The glove 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 D6978-05(2019) | Same | ||
| Material | Nitrile | Nitrile | Same |
| Powdered or Powder | |||
| Free | Powder Free | Powder Free | Same |
| Color | Blue | Blue | Same |
| Single use | Single use | Single use | Same |
| Chemotherapy Drugs | |||
| and Fentanyl Citrate and | |||
| other drugs Claim | See below comparison table | See below comparison table | See below |
| comparison | |||
| table |
Technological Characteristic Comparison Table:
| Technological
Characteristics | Proposed Device
K240051 | Predicate Device
K223320 | Result of
comparison |
|----------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|-------------------------|
| Length | Minimum 220mm for size XS and S, 230mm for size M, L, XL, XXL | Minimum 220mm for size XS and S, 230mm for size M, L, XL, XXL | Same |
| 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 | 130±10 | Same |
| Thickness(mm) | | | |
| Finger | Minimum 0.05 | Minimum 0.05 | Same |
8
| Palm | Minimum 0.05 | Minimum 0.05 | Same |
|---|---|---|---|
| Tensile Strength, Before | |||
| Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, | |||
| Before Aging | 500%, min | 500%, min | |
| Tensile Strength, After | |||
| Accelerated Aging | 14MPa, min | 14MPa, min | Same |
| Ultimate Elongation, | |||
| After Accelerated Aging | 400%, min | 400%, min | Same |
| Watertight (1000ml) | 21 CFR 800.20 | ||
| ASTM D5151 | |||
| G-1, AQL 2.5 | 21 CFR 800.20 | ||
| ASTM D5151 | |||
| G-1, AQL 2.5 | |||
| Powder-Content | ≤ 2 mg per glove | ≤ 2 mg per glove | Same |
| 10993-23:2021 | |||
| Skin Irritation Study | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant | Same |
| 10993-10:2021 | |||
| Sensitization Study | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer | Same |
| 10993-5:2009 | |||
| Cytotoxicity Test | Under the conditions of this study, the test article extract showed potential toxicity to L929 cells. | ||
| Cytotoxicity concern was addressed by acute systemic toxicity testing. | Under the conditions of this study, the test article extract showed potential toxicity to L929 cells. | ||
| Cytotoxicity concern was addressed by acute systemic toxicity testing. | Same | ||
| ISO 10993-11:2017 | |||
| Acute Systemic toxicity study | Under the conditions of this study, there was no evidence of acute systemic toxicity. | Under the conditions of this study, there was no evidence of acute systemic toxicity. | Same |
Chemotherapy, Fentanyl Citrate & other drugs Permeation Comparison:
| Tested Chemotherapy Drug and
Concentration | Minimum BDT (Minutes) | | Result of
comparison |
|-----------------------------------------------|----------------------------|-----------------------------|-------------------------|
| | Proposed Device
K240051 | Predicate Device
K223320 | |
| Bleomycin Sulfate 15mg/ml (15000 ppm) | >240 | / | Different* |
| Busulfan 6mg/ml (6,000 ppm) | >240 | / | Different* |
| Carboplatin 10mg/ml (10,000 ppm) | >240 | / | Different* |
| Carmustine 3.3 mg/ml (3,300 ppm) | 29.1 | 13.5 | Similar |
| Cisplatin 1mg/ml (1,000 ppm) | >240 | >240 | Same |
| Cyclophosphamide 20mg/ml (20,000 ppm) | >240 | >240 | Same |
| Cytarabine, 100 mg/ml (100,000 ppm) | >240 | / | Different* |
| Dacarbazine 10 mg/ml (10,000 ppm) | >240 | >240 | Same |
| Daunorubicin HCL, 5 mg/ml (5,000 ppm) | >240 | / | Different* |
| Docetaxel , 10 mg/ml (10,000 ppm) | >240 | / | Different* |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | >240 | >240 | Same |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | >240 | / | Different* |
| Etoposide, 20 mg/ml (20,000 ppm) | >240 | >240 | Same |
| Fludarabine Phosphate, 25 mg/ml (25,000 ppm) | >240 | / | Different* |
9
| Fluorouracil, 50mg/ml (50,000ppm) | >240 | >240 | Same |
|---|---|---|---|
| Gemcitabine HCL, 38mg/ml (38,000ppm) | >240 | / | Different* |
| Idarubicin HCL, 1mg/ml (1,000ppm) | >240 | / | Different* |
| Ifosfamide, 50mg/ml (50,000ppm) | >240 | / | Different* |
| Irinotecan HCL, 20mg/ml (20,000ppm) | >240 | / | Different* |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | >240 | / | Different* |
| Melphalan HCL, 5mg/ml (5,000ppm) | >240 | / | Different* |
| Methotrexate, 25mg/ml (25,000ppm) | >240 | >240 | Same |
| Mitomycin C, 0.5mg/ml (500ppm) | >240 | / | Different* |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | >240 | / | Different* |
| Oxaliplatin, 5mg/ml (5,000ppm) | >240 | / | Different* |
| Paclitaxel, 6mg/ml (6,000ppm) | >240 | >240 | Same |
| Paraplatin, 10mg/ml (10,000ppm) | >240 | / | Different* |
| Rituximab, 10mg/ml (10,000ppm) | >240 | / | Different* |
| Thiotepa, 10mg/ml (10,000ppm) | 78.3 | 66.6 | Similar |
| Topotecan HCL, 1mg/ml (1,000ppm) | >240 | / | Different* |
| Trisenox (Arsenic Trioxide), 1mg/ml (1,000ppm) | >240 | / | Different* |
| Velcade (Bortezomib), 1mg/ml (1,000ppm) | >240 | / | Different* |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | >240 | / | Different* |
| Fentanyl Citrate & other drugs | Minimum BDT (Minutes) | Result of | |
| Subject Device | Predicate Device | comparison | |
| K240051 | K223320 | ||
| Fentanyl Citrate Injection (100 mcg/2ml) | >240 | >240 | Same |
| Chloroquine 50mg/ml (50,000ppm) | >240 | / | Different* |
| Cyclosporin A 100 mg/ml (100,000 ppm) | >240 | / | Different* |
| Retrovir, 10mg/ml (10,000ppm) | >240 | / | Different* |
*This different is support with test report and will be indicated on labeling, so this different does not raise questions of safety and effectiveness of subject device.
8. Summary of Non-Clinical Performance Data
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Methodology | Test Performed | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319- 19 | Physical Dimensions | ||
| Length | Minimum 220mm for size XS and S, | ||
| 230mm for size M, L, XL, XXL | Pass | ||
| ASTM D6319- 19 | |||
| S: $80\pm10$ mm | |||
| M: $95\pm10$ mm | |||
| L: $110\pm10$ mm | |||
| XL: $120\pm10$ mm | |||
| XXL: $130\pm10$ mm | |||
| ASTM D6319- 19 | Physical Dimensions | ||
| Thickness | Finger: 0.05mm (min) | ||
| Palm: 0.05mm (min) | Pass |
10
| ASTM D6319- 19
ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min14 MPa) and
Elongation (Before Aging 500% and
after aging 400%) Min | Pass |
|-------------------------------------------|-----------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------|
| ASTM D6319- 19
ASTM D5151-19 | Water leak test | G-I, AQL 2.5 | Pass |
| ASTM D6319- 19
ASTM D6124-06
(2017) | Powder Residue | Max 2mg/glove | Pass |
| ASTM D6978-05
(2019) | Chemotherapy Drugs,
Opioid Drug Permeation | Refer the above tables | Pass |
| ISO 10993-10&-23 | Irritation and Skin
Sensitization | Skin sensitization and Skin irritation | non-sensitization
and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity | showed potential
toxicity to L929
cells. |
| ISO 10993-11:2017 | Acute systemic toxicity
study | Subject showed no adverse
biological reaction | no evidence of
acute systemic
toxicity. |
9. Summary of Clinical Information
No clinical testing was submitted for the subject device.
10. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.