(13 days)
No
The device is a physical product (examination gloves) and the description focuses on material properties, testing standards, and physical characteristics, with no mention of software, algorithms, or data processing that would involve AI/ML.
No
The device, Nitrile Examination Gloves, is intended to prevent contamination between patient and examiner and protect the user from chemotherapy drugs, not to treat a disease or condition.
No
The device is Nitrile Examination Gloves, which are used to prevent contamination between patients and examiners, and provide resistance to permeation by chemotherapy drugs. Its purpose is protective, not diagnostic.
No
The device is a physical product (gloves) and not software. The description details material composition, physical characteristics, and performance testing related to a tangible item.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical characteristics of the gloves and their compliance with standards related to physical properties and resistance to chemicals. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The testing for chemotherapy drug permeation is a safety feature for the user, not a diagnostic function.
N/A
Intended Use / Indications for Use
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use, powder-free, non-sterile device.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carboplatin | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 15.9 Minutes |
| Cisplatin | 1 mg/ml (1,000 ppm) | > 240 Minutes |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Cytarabine HCl | 100 mg/ml (100,000 ppm) | > 240 Minutes |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Docetaxel | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Doxorubicin HCl | 2 mg/ml (2,000 ppm) | > 240 Minutes |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50 mg/ml (50,000 ppm) | > 240 Minutes |
| Gemcitabine | 38 mg/ml (38,000 ppm) | > 240 Minutes |
| Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 Minutes |
| Irinotecan | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | > 240 Minutes |
| Melphalan | 5 mg/ml (5,000 ppm) | > 240 Minutes |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 Minutes |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 Minutes |
| Paclitaxel | 6 mg/ml (6,000 ppm) | > 240 Minutes |
| Thiotepa | 10 mg/ml (10,000 ppm) | 54.2 Minutes |
Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 15.9 Minutes Thiotepa 10 mg/m1 54.2 Minutes
Warning: Please do not use with Carmustine and Thiotepa.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ
Device Description
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Carboxylated Nitrile. These gloves are blue in color and are powder free. The product is non-sterile, textured, ambidextrous with beaded cuff and single use only.
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) with sizes X-Small, Small, Medium, Large, X-Large and XX-Large are included in the submission.
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)
Bench Test Data:
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT |
|---|---|---|---|
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. | To determine the length of the gloves | X-Small: 220 mm min; Small: 220 mm min; Medium: 230 mm min; Large: 230 mm min; X-Large: 230 mm min; XX-Large: 230 mm min | X-Small: 270 mm; Small: 273 mm; Medium: 274 mm; Large: 276 mm; X-Large: 278 mm; XX-Large: 276 mm |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. | To determine the width of the gloves | X-Small: 70+/-10 mm; Small: 80+/-10 mm; Medium: 95+/-10 mm; Large: 110+/-10 mm; X-Large: 120+/-10 mm; XX-Large: 130+/-10 mm | X-Small: 72 mm; Small: 82 mm; Medium: 97 mm; Large: 103 mm; X-Large: 112 mm; XX-Large: 126 mm |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. | To determine the thickness of the gloves | Palm: 0.05 mm min for all sizes; Finger: 0.05 mm min for all sizes | Size Palm Finger; X-Small 0.12 mm 0.14 mm; Small 0.12 mm 0.14 mm; Medium 0.12 mm 0.14 mm; Large 0.12 mm 0.14 mm; X-Large 0.12 mm 0.14 mm; XX-Large 0.12 mm 0.14 mm |
| ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application. | To determine the physical properties- Tensile strength | Before Ageing Tensile Strength 14MPa min for all sizes; After Ageing Tensile Strength 14MPa min for all sizes | Size Before ageing After ageing; X-Small 17.7 MPa 16.8 MPa; Small 18.1 MPa 17.3 MPa; Medium 18.3 MPa 17.2 MPa; Large 18.4 MPa 17.6 MPa; X-Large 18.2 MPa 17.5 MPa; XX-Large 18.5 MPa 17.6 MPa |
| (Not specified) | To determine the physical properties- Ultimate Elongation | Before Ageing Ultimate Elongation 500% min for all sizes; After Ageing Ultimate Elongation 400% min for all sizes | Size Before ageing After ageing; X-Small 637% 532%; Small 634% 539%; Medium 647% 542%; Large 630% 536%; X-Large 644% 529%; XX-Large 644% 533% |
| ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 2.5 | Gloves Passes AQL 2.5 |
| ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | ≤ 2 mg/glove | X-Small: 0.21 mg/glove; Small: 0.18 mg/glove; Medium: 0.18 mg/glove; Large: 0.19 mg/glove; X-Large: 0.21 mg/glove; XX-Large: 0.20 mg/glove |
| ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. | To determine the breakthrough detection time of chemotherapy drugs | Carboplatin 10 mg/ml (10,000 ppm) > 240 Minutes; Cisplatin 1 mg/ml (1,000 ppm) > 240 Minutes; Cyclophosphamide 20 mg/ml (20,000 ppm) > 240 Minutes; Cytarabine HCl 100 mg/ml (100,000 ppm) >240 Minutes; Dacarbazine 10 mg/ml (10,000 ppm) > 240 Minutes; Docetaxel 10 mg/ml (10,000 ppm) > 240 Minutes; Doxorubicin HCl 2 mg/ml (2,000 ppm) > 240 Minutes; Etoposide 20 mg/ml (20,000 ppm) > 240 Minutes; Fluorouracil 50 mg/ml (50,000 ppm) > 240 Minutes; Gemcitabine 38 mg/ml (38,000 ppm) >240 Minutes; Ifosfamide 50 mg/ml (50,000 ppm) >240 Minutes; Irinotecan 20 mg/ml (20,000 ppm) >240 Minutes; Mechlorethamine HCl 1 mg/ml (1,000 ppm) > 240 Minutes; Melphalan 5 mg/ml (5,000 ppm) > 240 Minutes; Methotrexate 25 mg/ml (25,000 ppm) >240 Minutes; Mitoxantrone 2 mg/ml (2,000ppm) > 240 Minutes; Paclitaxel 6 mg/ml (6,000 ppm) > 240 Minutes | Carboplatin 10 mg/ml (10,000 ppm) > 240 Minutes; Cisplatin 1 mg/ml (1,000 ppm) > 240 Minutes; Cyclophosphamide 20 mg/ml (20,000 ppm) > 240 Minutes; Cytarabine HCl 100 mg/ml (100,000 ppm) >240 Minutes; Dacarbazine 10 mg/ml (10,000 ppm) > 240 Minutes; Docetaxel 10 mg/ml (10,000 ppm) > 240 Minutes; Doxorubicin HCl 2 mg/ml (2,000 ppm) > 240 Minutes; Etoposide 20 mg/ml (20,000 ppm) > 240 Minutes; Fluorouracil 50 mg/ml (50,000 ppm) > 240 Minutes; Gemcitabine 38 mg/ml (38,000 ppm) >240 Minutes; Ifosfamide 50 mg/ml (50,000 ppm) >240 Minutes; Irinotecan 20 mg/ml (20,000 ppm) >240 Minutes; Mechlorethamine HCl 1 mg/ml (1,000 ppm) >240 Minutes; Melphalan 5 mg/ml (5,000 ppm) >240 Minutes; Methotrexate 25 mg/ml (25,000 ppm) >240 Minutes; Mitoxantrone 2 mg/ml (2,000ppm) > 240 Minutes; Paclitaxel 6 mg/ml (6,000 ppm) > 240 Minutes |
Biocompatibility Data:
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT |
|---|---|---|---|
| ISO 10993-23 First edition 2021-01 Biological Evaluation of Medical Devices - Part 23, Tests for Irritation. | To evaluate the test item, for skin irritation test in New Zealand White rabbits. | Under the condition of study not an irritant | Under the condition of study, not an irritant |
| 10993-10 Fourth edition 2021-11 Biological Evaluation of Medical Devices - Part 10, Tests for Skin Sensitization. | To evaluate the test item, for the skin sensitization in Guinea pigs by maximization test. | Under the conditions of the study, not a sensitizer | Under the conditions of the study, not a sensitizer |
| ISO 10993-5 Third edition 2009-06-01 Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity. | To evaluate the test item, for its ability to induce cytotoxicity using L-929 mouse fibroblast cells by Elution Method. | Under the conditions of the study, non-cytotoxic | Under the conditions of the study, non-cytotoxic |
| ISO 10993-11 Third edition 2017-09 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity. | To evaluate the test item, for acute systemic toxicity in Sprague Dawley Rats. | Under the conditions of study, the device extracts do not pose a systemic toxicity concern | Under the conditions of the study, the test item did not produce any adverse effect |
Key results
The non-clinical testing demonstrates that the subject device meets the specified standards for dimensions, physical properties (tensile strength, ultimate elongation), freedom from holes, residual powder, and resistance to permeation by chemotherapy drugs. Biocompatibility tests show the device is not an irritant, not a sensitizer, and non-cytotoxic, and does not cause systemic toxicity. The device is shown to be substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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.
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 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.
October 26, 2022
PT. Sintong Unigolden Glove % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. STE 114 Aurora, Illinois 60504
Re: K223235
Trade/Device Name: Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ Dated: October 19, 2022 Received: October 19, 2022
Dear Manoj Zacharias:
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.
Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223235
Device Name
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
Indications for Use (Describe)
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with cherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use, powderfree, non-sterile device.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carboplatin | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 15.9 Minutes |
| Cisplatin | 1 mg/ml (1,000 ppm) | > 240 Minutes |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Cytarabine HCl | 100 mg/ml (100,000 ppm) | > 240 Minutes |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Docetaxel | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Doxorubicin HCl | 2 mg/ml (2,000 ppm) | > 240 Minutes |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50 mg/ml (50,000 ppm) | > 240 Minutes |
| Gemcitabine | 38 mg/ml (38,000 ppm) | > 240 Minutes |
| Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 Minutes |
| Irinotecan | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | > 240 Minutes |
| Melphalan | 5 mg/ml (5,000 ppm) | > 240 Minutes |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 Minutes |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 Minutes |
| Paclitaxel | 6 mg/ml (6,000 ppm) | > 240 Minutes |
| Thiotepa | 10 mg/ml (10,000 ppm) | 54.2 Minutes |
Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 15.9 Minutes Thiotepa 10 mg/m1 54.2 Minutes
Warning: Please 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
A. APPLICANT INFORMATION
| 510(K) Owner's Name | PT. Sintong Unigolden Glove |
|---|---|
| Address | Jl. Lintas Sumatera, Kel. Hessa Perlompongan, |
| Kec. Air Batu, Kab. Asahan, Kota Kisaran, | |
| Sumatera Utara, Indonesia 21272 | |
| Phone | +62623533339 |
| Fax | +62623533330 |
| sug.qualityassurance@gmail.com | |
| Contact Person | Vivekanandan |
| Designation | Production Manager |
| Contact Number | +681253206449 |
| Contact Email | vivekmp80@gmail.com |
| Date Submitted | 13 October 2022 |
B. DEVICE IDENTIFICATION
| Name of the device | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) |
|---|---|
| Product proprietary or trade name | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) |
| Common or usual name | Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) |
| Classification name | Patient Examination Glove, Specialty |
| Device Classification | Class-1 |
| Product Code | LZA, LZC, OPJ |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Nitrile Patient Examination Gloves Blue Colored
Tested For Use With Chemotherapy Drugs |
|------------------|-------------------------------------------------------------------------------------------|
| 510(k) Number | K213040 |
| Regulatory Class | Class 1 |
| Product code | LZA, LZC, OPJ |
| Reference Device | Non-Sterile Nitrile Powder Free Examination
Gloves - Blue, Green and Black color |
|------------------|-------------------------------------------------------------------------------------|
| 510(k) Number | K210388 |
| Regulatory Class | Class 1 |
| Product code | LZA |
5
D. DESCRIPTION OF THE DEVICE:
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a Class I patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Carboxylated Nitrile. These gloves are blue in color and are powder free. The product is non-sterile, textured, ambidextrous with beaded cuff and single use only.
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) with sizes X-Small, Small, Medium, Large, X-Large and XX-Large are included in the submission.
E. INDICATION FOR USE OF THE DEVICE:
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. This is a single-use, powder-free, non-sterile device.
| Chemotherapy Drug | Concentration | Breakthrough Detection Time in Minutes |
|---|---|---|
| Carboplatin | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Carmustine | 3.3 mg/ml (3,300 ppm) | 15.9 Minutes |
| Cisplatin | 1 mg/ml (1,000 ppm) | > 240 Minutes |
| Cyclophosphamide | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Cytarabine HCl | 100 mg/ml (100,000 ppm) | > 240 Minutes |
| Dacarbazine | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Docetaxel | 10 mg/ml (10,000 ppm) | > 240 Minutes |
| Doxorubicin HCl | 2 mg/ml (2,000 ppm) | > 240 Minutes |
| Etoposide | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Fluorouracil | 50 mg/ml (50,000 ppm) | > 240 Minutes |
| Gemcitabine | 38 mg/ml (38,000 ppm) | > 240 Minutes |
| Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 Minutes |
| Irinotecan | 20 mg/ml (20,000 ppm) | > 240 Minutes |
| Mechlorethamine HCl | 1 mg/ml (1,000 ppm) | > 240 Minutes |
| Melphalan | 5 mg/ml (5,000 ppm) | > 240 Minutes |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 Minutes |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 Minutes |
| Paclitaxel | 6 mg/ml (6,000 ppm) | > 240 Minutes |
| Thiotepa | 10 mg/ml (10,000 ppm) | 54.2 Minutes |
The tested chemotherapy drugs and their breakthrough detection times are as follows:
6
Please note that the following drugs have low permeation times: Carmustine (3.3 mg/ml) 15.9 Minutes Thiotepa (10 mg/ml) 54.2 Minutes Warning: Do not use with Carmustine & Thiotepa
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||
| 510(K) Number | --- | K213040 | K210388 | K223235 | |
| Name of device | --- | Nitrile Patient | |||
| Examination Gloves | |||||
| Blue Colored Tested | |||||
| For Use With | |||||
| Chemotherapy Drugs | Non Sterile | ||||
| Nitrile | |||||
| Powder Free | |||||
| Examination | |||||
| Gloves – | |||||
| Blue, Green | |||||
| And Black | |||||
| color | Nitrile Examination | ||||
| Gloves Powder Free | |||||
| (Tested for use with | |||||
| Chemotherapy Drugs) | Similar | ||||
| to | |||||
| predicate | |||||
| device | |||||
| Product Code | --- | LZA, LZC, OPJ | LZA | LZA, LZC, OPJ | Similar to |
| predicate | |||||
| device | |||||
| Indication for use | --- | The blue colored nitrile | |||
| examination glove is | |||||
| intended to be worn on | |||||
| the hands of examiner's | |||||
| to prevent | |||||
| contamination | |||||
| between patient and | |||||
| examiner. This is a | |||||
| single-use, powder-free, | |||||
| non-sterile device. | |||||
| The Nitrile Patient | |||||
| Examination Gloves | |||||
| Blue Colored were | |||||
| tested for use with | |||||
| chemotherapy drugs per | |||||
| ASTM D6978-05 | |||||
| (Reapproved 2019) | |||||
| Standard Practice for | |||||
| Assessment of Medical | |||||
| Gloves to Permeation | |||||
| by Chemotherapy | |||||
| Drugs. | A powder | ||||
| free patient | |||||
| examination | |||||
| glove is a | |||||
| disposable | |||||
| device | |||||
| intended for | |||||
| medical | |||||
| purposes that | |||||
| is worn on | |||||
| the | |||||
| examiner's | |||||
| hand or | |||||
| finger to | |||||
| prevent | |||||
| contaminatio | |||||
| n between | |||||
| patient and | |||||
| examiner. | Nitrile Examination | ||||
| Gloves Powder Free | |||||
| (Tested for use with | |||||
| Chemotherapy Drugs) is | |||||
| a disposable device | |||||
| intended for medical | |||||
| purpose that is worn on | |||||
| the examiner's hand to | |||||
| prevent contamination | |||||
| between patient and | |||||
| examiner. In addition, | |||||
| these gloves were tested | |||||
| for use with | |||||
| chemotherapy drugs in | |||||
| accordance with ASTM | |||||
| D6978-05 (2019) | |||||
| Standard Practice for | |||||
| Assessment of | |||||
| Resistance of Medical | |||||
| Gloves to Permeation | |||||
| by Chemotherapy | |||||
| Drugs. This is a single- | |||||
| use, powder-free, non- | |||||
| sterile device. | Similar to | ||||
| predicate | |||||
| device | |||||
| Regulation Number | --- | 21 CFR 880.6250 | 21 CFR | ||
| 880.6250 | 21 CFR 880.6250 | Same | |||
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
| PREDICATE | REFERENCE | SUBJECT | |||
| 510(K) Number | --- | K213040 | K210388 | K223235 | |
| Material | Powder-Free Nitrile | Carboxylated | |||
| Butadiene | |||||
| Acrylonitrile as | |||||
| base material | Carboxylated Nitrile | ||||
| Rubber | Same as the | ||||
| reference | |||||
| device | |||||
| Color | --- | Blue | Blue, Green and | ||
| Black | Blue | Same as | |||
| predicate | |||||
| device | |||||
| Size | --- | X-Small, Small, | |||
| Medium, Large, X- | |||||
| Large and | |||||
| XX-Large | Small, Medium, | ||||
| Large and | |||||
| X-Large | X-Small, Small, | ||||
| Medium, Large, X- | |||||
| Large and | |||||
| XX-Large | Same as | ||||
| predicate | |||||
| device | |||||
| Single Use | --- | Single Use | Single Use | Single Use | Same |
| Sterile/non sterile | --- | non sterile | non sterile | non sterile | Same |
| Rx Only or OTC | --- | Over the Counter | Over the | ||
| Counter | Over the Counter | Same | |||
| Dimensions - Length | ASTM | ||||
| D6319-19 | XS (220mm min) | ||||
| S (220mm min) | |||||
| M (230mm min) | |||||
| L (230mm min) | |||||
| XL (230mm min) | |||||
| XXL (230mm min) | 240-246 mm | ||||
| (Medium) | XS (220mm min) | ||||
| S (220mm min) | |||||
| M (230mm min) | |||||
| L (230mm min) | |||||
| XL (230mm min) | |||||
| XXL (230mm min) | Same as | ||||
| predicate | |||||
| device |
Size Average
value
X- Small 270
Small 273
Medium 274
Large 276
X-Large 278
XX-Large 276 |
| Dimensions - Width | ASTM
D6319-19 | XS (70±10mm)
S (80±10mm)
M (95±10mm)
L(110±10mm)
XL (120±10mm)
XXL (≥120mm) | 95-98 mm
(Medium) | XS (70±10mm)
S (80±10mm)
M (95±10mm)
L(110±10mm)
XL (120±10mm)
XXL (130±10mm) | Similar
Size Average
value
X-Small 72
Small 82
Medium 97
Large 103
X-Large 112
XX-Large 126 |
7
8
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||||||||||||||||
| 510(K) Number | --- | K213040 | K210388 | K223235 | |||||||||||||||
| Physical Properties-Tensile Strength | ASTM D6319-2019 | Before Ageing | |||||||||||||||||
| Tensile Strength | |||||||||||||||||||
| ≥14MPa, min | Before Ageing | ||||||||||||||||||
| Tensile Strength | |||||||||||||||||||
| 25.9-32.0 MPa | |||||||||||||||||||
| (Medium) | Before Ageing | ||||||||||||||||||
| Tensile Strength | |||||||||||||||||||
| 14MPa, min | Similar | ||||||||||||||||||
| Size Average value X-Small 17.7 Small 18.1 Medium 18.3 Large 18.4 X-Large 18.2 XX-Large 18.5 | |||||||||||||||||||
| After Ageing | |||||||||||||||||||
| Tensile Strength | |||||||||||||||||||
| ≥14MPa, min | After Ageing | ||||||||||||||||||
| Tensile Strength | |||||||||||||||||||
| 25.4-34.0 MPa | |||||||||||||||||||
| (Medium) | After Ageing | ||||||||||||||||||
| Tensile Strength | |||||||||||||||||||
| 14MPa, min | Similar | ||||||||||||||||||
| Size Average value X-Small 16.8 Small 17.3 Medium 17.2 Large 17.6 X-Large 17.5 XX-Large 17.6 | |||||||||||||||||||
| Physical Properties-Ultimate Elongation | ASTM D6319-2019 | Before Ageing | |||||||||||||||||
| Ultimate | |||||||||||||||||||
| Elongation | |||||||||||||||||||
| 500% min | Before Ageing | ||||||||||||||||||
| Ultimate | |||||||||||||||||||
| Elongation | |||||||||||||||||||
| 500-540 % | |||||||||||||||||||
| (Medium) | Before Ageing | ||||||||||||||||||
| Ultimate Elongation | |||||||||||||||||||
| 500% min | Same as | ||||||||||||||||||
| predicate | |||||||||||||||||||
| device | |||||||||||||||||||
| Size Average value X-Small 637 Small 634 Medium 647 Large 630 X-Large 644 XX-Large 644 | |||||||||||||||||||
| After Ageing | |||||||||||||||||||
| Ultimate | |||||||||||||||||||
| Elongation | |||||||||||||||||||
| 400% min | After Ageing | ||||||||||||||||||
| Ultimate | |||||||||||||||||||
| Elongation | |||||||||||||||||||
| 480-520 % | |||||||||||||||||||
| (Medium) | After Ageing | ||||||||||||||||||
| Ultimate Elongation | |||||||||||||||||||
| 400% min | Same as | ||||||||||||||||||
| predicate | |||||||||||||||||||
| device | |||||||||||||||||||
| Size Average value X-Small 532 Small 539 Medium 542 Large 536 X-Large 529 XX-Large 533 |
9
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | ||||||||||||||||||||||||
| 510(K) Number | K213040 | K210388 | K223235 | |||||||||||||||||||||||
| Thickness | ASTM | |||||||||||||||||||||||||
| D6319-19 | Palm | |||||||||||||||||||||||||
| 0.05mm min | Palm | |||||||||||||||||||||||||
| 0.06-0.06 mm | ||||||||||||||||||||||||||
| (Medium) | Palm 0.05 mm min; | |||||||||||||||||||||||||
| Finger 0.05 mm min | Similar | |||||||||||||||||||||||||
| Finger | ||||||||||||||||||||||||||
| 0.11 mm min | Finger | |||||||||||||||||||||||||
| 0.09-0.10 mm | ||||||||||||||||||||||||||
| (Medium) | Size Palm | |||||||||||||||||||||||||
| (Avg value) Finger | ||||||||||||||||||||||||||
| (Avg value) X-Small 0.12 0.14 Small 0.12 0.14 Medium 0.12 0.14 Large 0.12 0.14 X-Large 0.12 0.14 XX-Large 0.12 0.14 | ||||||||||||||||||||||||||
| Powder Free Residue | ASTM D6319- | |||||||||||||||||||||||||
| 19 | 240 min. | |||||||||||||||||||||||||
| Carboplatin 10 mg/ml |
240 min.
Carmustine (BCNU)
3.3 mg/ml 17.2 min.
Cisplatin 1.0 mg/ml
240 min.
Cyclophosphamide
(Cytoxan)
20.0 mg/ml >240 min.
Cytarabine HCl
100 mg/ml >240 min.
Dacarbazine (DTIC)
10.0 mg/ml >240 min.
Daunorubicin
5.0 mg/ml >240 min.
Docetaxel 10.0 mg/ml
240 min | NA | Not tested
Carboplatin 10 mg/ml
(10,000 ppm) > 240 Minutes
Carmustine 3.3 mg/ml
(3,300 ppm) 15.9 Minutes
Cisplatin 1 mg/ml
(1,000 ppm) > 240 Minutes
Cyclophosphamide 20 mg/ml
(20,000 ppm) > 240 Minutes
Cytarabine HCl
100 mg/ml (100,000 ppm)
240 Minutes
Dacarbazine 10 mg/ml
(10,000 ppm) > 240 Minutes
Not tested
Docetaxel 10 mg/ml
(10,000 ppm) >240 Minutes | Optional*
Same
Similar
Same
Same
Same
Same
Optional*
Same | | | | | | | | | | | | | | | | | | | | | |
10
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE | Comparison | ||
|---|---|---|---|---|---|
| PREDICATE | REFERENCE | SUBJECT | |||
| 510(K) Number | K213040 | K210388 | K223235 | ||
| Chemotherapy Drugs | |||||
| Tested with Minimum | |||||
| Breakthrough | |||||
| Detection Time | ASTM | ||||
| D6978-05 | |||||
| (2019) | Doxorubicin HCl | ||||
| 2.0 mg/ml >240 min. | NA | Doxorubicin HCl 2 mg/ml | |||
| (2,000 ppm) > 240 Minutes | Same | ||||
| Etoposide (Toposar) | |||||
| 20.0 mg/ml >240 min. | NA | Etoposide 20 mg/ml | |||
| (20,000 ppm) > 240 Minutes | Same | ||||
| Fluorouracil | |||||
| 50.0 mg/ml >240 min. | NA | Fluorouracil 50 mg/ml | |||
| (50,000 ppm) > 240 Minutes | Same | ||||
| Gemcitabine | |||||
| 38 mg/ml >240 min. | NA | Gemcitabine 38 mg/ml | |||
| (38,000 ppm) >240 Minutes | Same | ||||
| Idarubicin 1 mg/ml |
240 min. | NA | Not tested | Optional* |
| | | Ifosfamide 50.0 mg/ml
240 min. | NA | Ifosfamide 50 mg/ml
(50,000 ppm) >240 Minutes | Same |
| | | Irinotecan 20.0 mg/ml
240 min. | NA | Irinotecan 20 mg/ml
(20,000 ppm) >240 Minutes | Same |
| | | Mechlorethamine HCl
1.0 mg/ml >240 min. | NA | Mechlorethamine HCl
1 mg/ml (1,000 ppm)
240 Minutes | Same |
| | | Melphalan 5 mg/ml
240 min. | NA | Melphalan 5 mg/ml
(5,000 ppm) >240 Minutes | Same |
| | | Methotrexate
25 mg/ml >240 min. | NA | Methotrexate 25 mg/ml
(25,000 ppm) >240 Minutes | Same |
| | | Mitromycin C.
0.5 mg/ml >240 min. | NA | Not tested | Optional* |
| | | Mitoxantrone
2.0 mg/ml >240 min. | NA | Mitoxantrone 2 mg/ml
(2,000ppm) > 240 Minutes | Same |
| | | Paclitaxel (Taxol)
6.0 mg/ml >240 min. | NA | Paclitaxel 6 mg/ml
(6,000 ppm) > 240 Minutes | Same |
| | | Thiotepa 10.0 mg/ml
13.9 min. | NA | Thiotepa 10 mg/ml
(10,000 ppm) 54.2 Minutes | Similar |
| | | Vincristine Sulfate
1.0 mg/ml >240 min. | NA | Not tested | Optional* |
| Contact Durations | --- | Limited 240 Minutes | Carboplatin 10 mg/ml
(10,000 ppm) > 240 Minutes |
| | | Cisplatin 1 mg/ml
(1,000 ppm) > 240 Minutes | Cisplatin 1 mg/ml
(1,000 ppm) > 240 Minutes |
| | | Cyclophosphamide 20 mg/ml
(20,000 ppm) > 240 Minutes | Cyclophosphamide 20 mg/ml
(20,000 ppm) > 240 Minutes |
| | | Cytarabine HCl 100 mg/ml
(100,000 ppm) >240 Minutes | Cytarabine HCl 100 mg/ml
(100,000 ppm) >240 Minutes |
| | | Dacarbazine 10 mg/ml
(10,000 ppm) > 240 Minutes | Dacarbazine 10 mg/ml
(10,000 ppm) > 240 Minutes |
| | | Docetaxel 10 mg/ml
(10,000 ppm) > 240 Minutes | Docetaxel 10 mg/ml
(10,000 ppm) > 240 Minutes |
13
| TEST METHOD | PURPOSE | ACCEPTANCE CRITERIA | RESULT |
|---|---|---|---|
| ASTM D6978-05 | |||
| (Reapproved 2019) | |||
| Standard Practice for | |||
| Assessment of | |||
| Resistance of | |||
| Medical Gloves to | |||
| Permeation by | |||
| Chemotherapy | |||
| Drugs. | To determine the | ||
| breakthrough | |||
| detection time of | |||
| chemotherapy | |||
| drugs | Doxorubicin HCl 2 mg/ml | ||
| (2,000 ppm) > 240 Minutes | |||
| Etoposide 20 mg/ml | |||
| (20,000 ppm) > 240 Minutes | |||
| Fluorouracil 50 mg/ml | |||
| (50,000 ppm) > 240 Minutes | |||
| Gemcitabine 38 mg/ml | |||
| (38,000 ppm) >240 Minutes | |||
| Ifosfamide 50 mg/ml | |||
| (50,000 ppm) >240 Minutes | |||
| Irinotecan 20 mg/ml | |||
| (20,000 ppm) >240 Minutes | |||
| Mechlorethamine HCl 1 mg/ml | |||
| (1,000 ppm) > 240 Minutes | |||
| Melphalan 5 mg/ml | |||
| (5,000 ppm) > 240 Minutes | |||
| Methotrexate 25 mg/ml | |||
| (25,000 ppm) >240 Minutes | |||
| Mitoxantrone 2 mg/ml | |||
| (2,000ppm) > 240 Minutes | |||
| Paclitaxel 6 mg/ml | |||
| (6,000 ppm) > 240 Minutes | Doxorubicin HCl 2 mg/ml | ||
| (2,000 ppm) > 240 Minutes | |||
| Etoposide 20 mg/ml | |||
| (20,000 ppm) > 240 Minutes | |||
| Fluorouracil 50 mg/ml | |||
| (50,000 ppm) > 240 Minutes | |||
| Gemcitabine 38 mg/ml | |||
| (38,000 ppm) >240 Minutes | |||
| Ifosfamide 50 mg/ml | |||
| (50,000 ppm) >240 Minutes | |||
| Irinotecan 20 mg/ml | |||
| (20,000 ppm) >240 Minutes | |||
| Mechlorethamine HCl 1 mg/ml | |||
| (1,000 ppm) >240 Minutes | |||
| Melphalan 5 mg/ml | |||
| (5,000 ppm) >240 Minutes | |||
| Methotrexate 25 mg/ml | |||
| (25,000 ppm) >240 Minutes | |||
| Mitoxantrone 2 mg/ml | |||
| (2,000ppm) > 240 Minutes | |||
| Paclitaxel 6 mg/ml | |||
| (6,000 ppm) > 240 Minutes |
BIOCOMPATIBILITY DATA
| TEST METHOD | PURPOSE | ACCEPTANCE
CRITERIA | RESULT |
|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| ISO 10993-23 First edition
2021-01 Biological
Evaluation of Medical
Devices - Part 23, Tests for
Irritation. | To evaluate the test item, for
skin irritation test in New
Zealand White rabbits. | Under the condition
of study not an
irritant | Under the condition of
study, not an irritant |
| 10993-10 Fourth edition
2021-11 Biological
Evaluation of Medical
Devices - Part 10, Tests for
Skin Sensitization. | To evaluate the test item, for
the skin sensitization in Guinea
pigs by maximization test. | Under the conditions
of the study, not a
sensitizer | Under the conditions of
the study, not a sensitizer |
| ISO 10993-5 Third edition
2009-06-01 Biological
Evaluation of Medical
Devices - Part 5, Tests for In
Vitro Cytotoxicity. | To evaluate the test item, for its
ability to induce cytotoxicity
using L-929 mouse fibroblast
cells by Elution Method. | Under the conditions
of the study, non-
cytotoxic | Under the conditions of
the study, non-cytotoxic |
| ISO 10993-11 Third edition
2017-09 Biological
Evaluation of Medical
Devices - Part 11, Tests for
Systemic Toxicity. | To evaluate the test item, for
acute systemic toxicity in
Sprague Dawley Rats. | Under the conditions
of study, the device
extracts do not pose a
systemic toxicity
concern | Under the conditions of
the study, the test item did
not produce any adverse
effect |
14
The performance test data of the non-clinical tests that support a determination of safety and equivalence is the same as mentioned above (ASTM Requirements).
The performance test data of the non-clinical tests meet following standards:
ASTM D6319-19 Standard Specification for Nitrile examination Gloves for Medical Application.
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves.
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves.
ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
ISO 10993-23 First Edition 2021-01 Biological Evaluation of Medical Devices - Part 23, Tests for Irritation.
ISO 10993-10 Fourth Edition 2021-11 Biological Evaluation of Medical Devices - Part 10, Tests for Skin Sensitization.
ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices - Part 5, Tests for In Vitro Cytotoxicity.
ISO 10993-11 Third Edition 2017-09 Biological Evaluation of Medical Devices - Part 11, Tests for Systemic Toxicity.
H. CLINICAL TESTING SUMMARY
Not applicable - Clinical data is not needed for gloves.
I. CONCLUSION
The conclusions drawn from the non-clinical test demonstrate that the subject device in 510(K) submission, Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicate device K213040.