(82 days)
Not Found
No
The device is a physical examination glove and the summary describes standard material and performance testing, with no mention of AI or ML.
No.
The device is a glove intended to prevent contamination and protect the wearer, not to treat a disease or condition.
No
This device is a medical glove, described as a "disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient." Its primary function is protection, not diagnosis.
No
The device description and performance studies clearly indicate that this is a physical medical device (examination gloves) and not a software-only device. The testing focuses on material properties and resistance to chemicals, not software functionality.
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 a "disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient." It also mentions protection against chemotherapy drugs and Fentanyl Citrate. This describes a barrier device used for protection during medical procedures.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description of the device, its intended use, and the performance studies do not involve testing samples from the human body or diagnosing any condition. The tests performed are related to the physical properties of the glove and its resistance to chemical permeation.
Therefore, the Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a medical device, but it falls under the category of a protective barrier device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these qloves are worn to protect the wearer aqainst exposure to chemotherapy drugs. Tested for use chemotherapy drugs and Fentanyl Citrate. Tested chemotherapy drugs are as follows:
Cisplatin 1.0 mg/ml ≥ 240
Cyclophosphamide (Cytoxan) 20 mg/ml ≥ 240
Dacarbazine (DTIC) 10.0 mg/ml ≥ 240
Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240
Etoposide (Toposar) 20.0 mg/ml ≥ 240
Fluorouracil 50.0 mg/ml ≥ 240
Paclitaxel (Taxol) 6.0 mg/ml ≥ 240
*Carmustine (BCNU) 3.3mg.ml 54.1 (minutes)
*Thiotepa 10.0 mg/ml 6.0 (minutes)
*Please note that these drugs have extremely low permeation time CAUTION: Testing showed an average breakthrough time of 54.1 minutes with Carmustine. WARNING: Do not use with Thiotepa.
Tested Fentanyl Citrate is as follows: Fentanyl Citrate Injection 100.0 mcg/2ml ≥ 240
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate meets the requirements of ASTM D6319-10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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 demonstrate that the proposed device met design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
- ASTM D412-2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic . Elastomers-Tension
- ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber- Deterioration . in an Air Oven
- ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions ●
- ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes in . Medical Gloves
- ASTM D6124-2006 (Reapproved 2001) Standard Tested Method for Residual Powder on ● Medical Gloves
- ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical ● Application
- ASTM D6978-2005(Reapproved 2019) Standard Practice for Assessment of Resistance . of Medical Gloves to Permeation by Chemotherapy Drugs
- ISO 2859 Sampling Procedures and Tables for Inspection by Attributes ●
- ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vivo cytotoxicity ●
- ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and . delayed-type hypersensitivity
Key results:
- Dimension (length, width, thickness): Met Acceptance Number based on ASTM D6319-10(2015) ANSI / ASQC 21.4-2003 with Inspection Level S-2 and AQL 4.0.
- Tensile strength and Ultimate elongation: Met Acceptance Number based on ASTM D 6319 - 10(2015) ANSI / ASQC 21.4-2003 with Inspection Level S-2 and AQL 4.0.
- Tensile Strength: Mean of 21.36 MPA (Unaged) and 20.49 MPA (Aged, 70°C). Minimum of 15.32 MPA (Unaged) and 16.44 MPA (Aged). Pass (Minimum 16.44 MPa).
- Elongation At Break: Mean of 585% (Unaged) and 475% (Aged, 70°C). Minimum of 520% (Unaged) and 427% (Aged). Pass (Minimum 427 %).
- Water Leak: Met Acceptance Number based on FDA 1000ml water leak test method (21CFR 800.20) ANSI / ASQC 21.4-2003 with Inspection Level G-1 and AQL 1.5.
- Powder Residue: 2 mg/glove based on ASTM D6124 - 06(2011). Test Result: 0.50 mg/glove.
- Freedom From Holes: Pass (No. Of Defective = 0) from 80 samples tested.
- Chemotherapy Drugs Permeation:
- Carmustine (BCNU) (3.3 mg/ml): 54.1 minutes (average breakthrough detection time); Steady State Perm. Rate: 0.6 µg/Cm2/Minute. Moderate swelling and slight degradation observed.
- Cisplatin (1.0 mg/ml): >240 minutes; N/A Steady State Perm. Rate. No significant changes.
- Cyclophosphamide (Cytoxan) (20 mg/ml): >240 minutes; N/A Steady State Perm. Rate. No significant changes.
- Dacarbazine (10 mg/ml): >240 minutes; N/A Steady State Perm. Rate. No significant changes.
- Doxorubicin Hydrochloride (2.0 mg/ml): >240 minutes; N/A Steady State Perm. Rate. No significant changes.
- Etoposide (Toposar) (20.0 mg/ml): >240 minutes; N/A Steady State Perm. Rate. No significant changes.
- Fluorouracil (50 mg/ml): >240 minutes; N/A Steady State Perm. Rate. No significant changes.
- Paclitaxel (Taxol) (6.0 mg/ml): >240 minutes; N/A Steady State Perm. Rate. Slight swelling and no degradation.
- Thiotepa (THT) (10 mg/ml): 16.0 minutes (average breakthrough detection time); Steady State Perm. Rate: 0.4 µg/Cm2/Minute. No significant changes.
- Fentanyl Drug Permeation:
- Fentanyl Citrate Injection (100mcg/2mL): >240 minutes; N/A Steady State Perm. Rate. Slight swelling; no degradation.
- Biocompatibility: Non-irritating and non-sensitizing based on ISO 10993-10: 2010. Non-cytotoxic based on ISO 10993-5: 2009.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 29, 2022
Comfort Rubber Gloves Industries Sdn. Bhd. Ng Howe QA Manager Lot 821, Jalan Matang Matang, Perak 34750 Malaysia
Re: K200181
Trade/Device Name: Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA, LZC
Dear Ng Howe:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 15, 2020. Specifically, FDA is updating this SE Letter for a typographical error contained in the Indications for Use, as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Bifeng Qian, Office of Surgical and Infection Control Devices, at: (301) 796-2261 or bifeng.qian@fda.hhs.gov.
Sincerely,
Bifeng Qian -S
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
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized graphic of a human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 15, 2020
Comfort Rubber Gloves Industries Sdn. Bhd. Ng Howe QA Manager Lot 821, Jalan Matang Matang, 34750 My
Re: K200181
Trade/Device Name: Black Colored, Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC Dated: January 22, 2020 Received: January 24, 2020
Dear Ng Howe:
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/ofdocs/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.
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
2
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 (OS) 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,
Image /page/2/Picture/5 description: The image shows the name "Elizabeth F. Claverie -S" in a simple, sans-serif font. The text is arranged vertically, with "Elizabeth F." on the first line and "Claverie -S" on the second line. The background is plain white.
CAPT Elizabeth Claverie, M.S. 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
3
Indications for Use
510(k) Number (if known)
K200181
Device Name
Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Indications for Use (Describe)
The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these qloves are worn to protect the wearer aqainst exposure to chemotherapy drugs. Tested for use chemotherapy drugs and Fentanyl Citrate. Tested chemotherapy drugs are as follows:
| Average Breakthrough Detection Time (minutes) | |
|---|---|
| Cisplatin 1.0 mg/ml | ≥ 240 |
| Cyclophosphamide (Cytoxan) 20 mg/ml | ≥ 240 |
| Dacarbazine (DTIC) 10.0 mg/ml | ≥ 240 |
| Doxorubicin Hydrochloride 2.0 mg/ml | ≥ 240 |
| Etoposide (Toposar) 20.0 mg/ml | ≥ 240 |
| Fluorouracil 50.0 mg/ml | ≥ 240 |
| Paclitaxel (Taxol) 6.0 mg/ml | ≥ 240 |
| *Carmustine (BCNU) 3.3mg.ml | 54.1 (minutes) |
| *Thiotepa 10.0 mg/ml | 6.0 (minutes) |
*Please note that these drugs have extremely low permeation time CAUTION: Testing showed an average breakthrough time of 54.1 minutes with Carmustine. WARNING: Do not use with Thiotepa.
| Tested Fentanyl Citrate is as follows: | Fentanyl Citrate Injection 100.0 mcg/2ml |
|---|---|
| Average Breakthrough Detection Time (minutes) | ≥ 240 |
Prescription Use (Part 21 CFR 801 Subpart D)
| X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) SUMMARY
K200181
Prepared according to 21 CFR § 807.92 Preparation Date: April 10, 2020
1. Submitter
Name: Comfort Rubber Gloves Industries Sdn. Bhd. Address: Lot 821, Jalan Matang, 34750 Matang, Perak, Malaysia. Phone No.: 605-847 2777 Fax No .: 605-847 9108 Contact Person: Ng Kok Howe (Mr.)
2. Identification of the Device
Device name: Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Common Name: Patient Examination Gloves
Classification Name: Patient Examination Gloves
Regulation: 21 CFR 880.6250
Product code: LZA
Classification Name: Patient Examination Gloves Specialty
Regulation: 21 CFR 880.6250
Product code: LZC
3. Identification of the Legally Marketed Device as Predicate
Predicate Device Name: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Company: Kossan International Sdn. Bhd.
Predicate 510(K) No.: K183287
4. Description of the Device:
Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate meets the requirements of ASTM D6319-10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application.
5
| Reference
| Standard | Glove size | Standard Requirements | |
|---|---|---|---|
| Palm width (mm) | Length (mm) | ||
| ASTM 6319 | XS | $75 \pm 5$ mm | Min 240 |
| S | $85 \pm 5$ mm | ||
| M | $95 \pm 5$ mm | ||
| L | $105 \pm 5$ mm | ||
| XL | $115 \pm 5$ mm |
Table 1. Glove Specifications for different models
5. Indications for Use
The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs and Fentanyl Citrate. Tested for use with chemotherapy drugs and fentanyl citrate.
6. Comparison of the Technological Characteristics between the Subject and Predicate Devices
The Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate are summarized with the following technological characteristics compared to ASTM D6319 - 10(2015) Standard Specification for Nitrile Examination Gloves for Medical Application or equivalent standards as shown in Table 1. Chemotherapy claim is similar to the predicate.
| Characteristics | Standards | Device performance | Remarks | |
|---|---|---|---|---|
| Predicate device | Subject device | |||
| Manufacturer(s) | Kossan International Sdn. | |||
| Bhd. | Comfort Rubber Gloves | |||
| Industries Sdn. Bhd | - | |||
| 510(k) number | K183287 | K200181 | - | |
| Indication for Use | A patient examination | |||
| glove is a disposable device | ||||
| intended for medical | ||||
| purpose that is worn on the | ||||
| examiner's hand to prevent | ||||
| contamination between | ||||
| patient and examiner. | The Black Colored, Power | |||
| Free Nitrile Examination | ||||
| Gloves, Non-sterile, and | ||||
| Tested for Use with | ||||
| Chemotherapy Drugs and | ||||
| Fentanyl Citrate is a | ||||
| specialty medical glove | ||||
| which is a disposable device | ||||
| intended for medical purpose | ||||
| that is worn on the | ||||
| examiner's hand or finger to | ||||
| prevent contamination | ||||
| between examiner and | ||||
| patient. In addition, these | ||||
| gloves are worn to protect | ||||
| the wearer against exposure | ||||
| to chemotherapy drugs and | ||||
| Fentanyl Citrate. Tested for | ||||
| use with chemotherapy drugs | ||||
| and Fentanyl Citrate. Tested | ||||
| chemotherapy drugs are as | ||||
| follows: | Same | |||
| These gloves were tested | ||||
| for use with chemotherapy | ||||
| drugs and Fentanyl Citrate | ||||
| per ASTM D6978-05 | ||||
| (Reapproved 2013) | ||||
| Standard Practice for | ||||
| Assessment of Medical | ||||
| Gloves to Permeation by | ||||
| Chemotherapy Drugs. | ||||
| Minimum Breakthrough | ||||
| Detection Time in minutes | ||||
| Carmustine (BCNU) | ||||
| (3.3mg/ml) - 10.1 Cisplatin, | ||||
| (1.0 mg/ml) - >=240 | ||||
| Cyclophosphamide | Average Breakthrough | |||
| (Cytoxan), 20.0 mg/ml - >= | Detection Time (minutes) | |||
| 240 Cytarabine (100 mg/ml) | Cisplatin, 1.0 mg/ml - | |||
| >=240 | >=240 | |||
| Dacarbazine (DTIC), 10.0 | Cyclophosphamide | |||
| mg/ml >=240 | (Cytoxan), 20.0 mg/ml | |||
| Doxorubicin Hydrochloride, | ->=240 | |||
| (2.0 mg/ml) >=240 | Dacarbazine (DTIC), | |||
| Etoposide, (20.0 mg/ml) | 10.0 mg/ml - >=240 | |||
| >=240 | Doxorubicin Hydrochloride, | |||
| Fluorouracil, (50.0 mg/ml) | 2.0 mg/ml ->=240 | |||
| >=240 | Etoposide (Toposar), 20.0 | |||
| lfosfamide (50.0 mg/ml) | mg/ml ->=240 | |||
| >=240 | Fluorouracil, 50.0mg/ml - | |||
| Methotrexate (25.0 mg/ml) | >=240 | |||
| >=240 | Paclitaxel (Taxol), 6.0mg/ml | |||
| Mitomycin C (0.5 mg/ml) | >=240 | |||
| >=240 | *Carmustine (BCNU) | |||
| Mitoxantrone (2.0 mg/ml) | 3.3mg/ml - 54.1 (mins) | |||
| >=240 | *Thiotepa 10.0 mg/ml | |||
| Paclitaxel (Taxol), 6.0 mg/ml | - 16.0 (mins) | |||
| >=240 | *Please note that these drugs | |||
| Thiotepa (10.0 mg/ml) - 30.2 | have extremely low | |||
| Vincristine Sulfate (1.0mg/ml) | permeation time. | |||
| >=240. | CAUTION: Testing showed | |||
| Please note that Carmustine | an average breakthrough | |||
| (BCNU) has extremely low | time of 54.1 minutes with | |||
| permeation time of 10.1 | Carmustine; WARNING: Do | |||
| minutes. Fentanyl Citrate and | not use with Thiotepa. | |||
| Concertation Fentanyl Citrate | Tested Fentanyl Citrate is as | |||
| Injection (100.0 mcg/2ml) | follows: Fentanyl Citrate | |||
| Minimum Breakthrough | Injection 100.0 mcg/2ml | |||
| Detection Time in | Average Breakthrough | |||
| minutes>=240 | Detection Time | |||
| (minutes) >=240 | ||||
| ASTM D6319- | Length-Min 240mm | Length-Min 240mm Thickness | ||
| Dimension | 10(2015) | Thickness palm and finger- | palm and finger- Min 0.05mm | Similar |
| Min 0.05mm | ||||
| Physical Properties | ASTM D6319- | Meets | Meets | Similar |
| 10(2015) | ||||
| Thickness - Finger- | ASTM D6319- | Meets | Meets | Similar |
| Palm | 10(2015) | |||
| Powder Content | ASTM D6124- | Meets | Meets | Similar |
| 06(2011) | ||||
| Chemotherapy | Concentration | Minimum Breakthrough Detection Time (min) | ||
| Drugs | ||||
| Cisolatin | 1.0 mg/ml | >240 | >240 | Same |
| Cyclophosphamide | 20 mg/ml | >240 | >240 | Same |
| (Cvtoxan) | ||||
| Dacarbazine (DTIC) | 10.0 mg/ml | >240 | >240 | Same |
| Doxorubicin | 2 0 mg/ml | >240 | >240 | Same |
| Hvdrochloride | ||||
| Etoooside (Toposar) | 20.0 ma/ml | >240 | >240 | Same |
| Fluorouracil | 50.0 ma/ml | >240 | >240 | Same |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 | >240 | Same |
| lfosfamide | 50.0 ma/ml | >240 | - | Different |
| Mitoxantrone | 2.0 mg/ml | >240 | - | Different |
| Vincristine Sulfate | 1.0 mg/ml | >240 | - | Different |
| Carmustine (BCNU) | 3.3 mg/ml | 15.0 | 54.1 | Similar |
| Thiotepa | 10.0 mg/ml | 2.0 | 16.0 | Similar |
| Fentanyl Citrate | 100mcq/2ml | - | >240 | Different |
| Biocompatibility | ISO10993-10: 2010 | |||
| Biological | ||||
| evaluation of | ||||
| medical devices -- | ||||
| Part 10: Tests for | ||||
| irritation and skin | ||||
| Sensitization | Under the conditions of the | |||
| study, the subject device is | ||||
| non-irritating | Under the conditions of the | |||
| study, the subject device is | ||||
| non- irritating | Same | |||
| ISO10993-5: 2009 | Under the conditions of the | |||
| study, the subject device is | ||||
| non- sensitization | Under the conditions of the | |||
| study, the subject device is | ||||
| non- sensitization | Same | |||
| Biological | ||||
| Evaluation of | ||||
| Medical Devices- | ||||
| Part 5: Test for In | ||||
| Vitro Cytotoxicity | Under the conditions of the | |||
| study, the subject device is | ||||
| non- cytotoxic | Under the conditions of the | |||
| study, the subject device is non- | ||||
| cytotoxic | Same | |||
| Watertight (1000ml) | 21 CFR 800.20 | |||
| ASTM D5151 | Passes | Passes | Same | |
| Material | ASTM 06319 - | |||
| 10(2015) | Nitrile | Nitrite | Same | |
| Color | - | Blue White Black | Black | Same |
| Size | Medical Glove | |||
| Guidance Manual |
- Labeling | Extra small
Small
Medium
Large
Extra Large | Extra Small
Small
Medium
Large
Extra Large | Same |
| Single Use | Medical Glove
Guidance Manual - Labeling | Single Use | Single Use | Same |
Table 2. Comparison of the Technological Characteristics
6
7
The subject device and the predicate device share the same indication for use, same material, same specifications for thickness and length, similar permeation rate for chemotherapy drugs, similar labeling properties, powder free, biocompatibility and water tight test.
7. Summary of Non-Clinical tests
Non-clinical tests were conducted to demonstrate that the proposed device met design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
- ASTM D412-2016 Standard Test Methods for Vulcanized Rubber and Thermoplastic . Elastomers-Tension
- ASTM D573-2004 (Reapproved 2010) Standard Test Method for Rubber- Deterioration . in an Air Oven
- ASTM D3767-03 Standard Practice for Rubber Measurement of Dimensions ●
- ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes in . Medical Gloves
- ASTM D6124-2006 (Reapproved 2001) Standard Tested Method for Residual Powder on ● Medical Gloves
- ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical ● Application
- ASTM D6978-2005(Reapproved 2019) Standard Practice for Assessment of Resistance . of Medical Gloves to Permeation by Chemotherapy Drugs
- ISO 2859 Sampling Procedures and Tables for Inspection by Attributes ●
- ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vivo cytotoxicity ●
8
- ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and . delayed-type hypersensitivity
| Characteristics | Reference Test Method &Sampling | Inspection Level | AQL | Acceptance Criteria |
|---|---|---|---|---|
| Dimension (length, width, thickness) | ASTM D6319 - 10(2015) | |||
| ANSI / ASQC 21.4-2003 | S-2 | 4.0 | Meet Acceptance Number | |
| Tensile strength and | ||||
| Ultimate elongation | ASTM D 6319 - 10(2015) | |||
| ANSI / ASQC 21.4-2003 | S-2 | 4.0 | Meet Acceptance Number | |
| Water Leak | FDA 1000ml water leak test method | |||
| (21CFR 800.20) | ||||
| ANSI / ASQC 21.4-2003 | G-1 | 1.5 | Meet Acceptance Number | |
| Powder Residue | ASTM D6124 - 06(2011) | N/A | N/A | 2 mg/glove |
Table 3. Quality Assurance Testing For Finished Gloves
Table 4. Physical Property
| Sample | Unaged | Aged (7 Days, 70°C) | ||
|---|---|---|---|---|
| Tensile Strength | ||||
| (MPA) | Elongation At | |||
| Break (%) | Tensile Strength | |||
| (MPA) | Elongation At Break | |||
| (%) | ||||
| 1 | 22.86 | 596 | 20.80 | 447 |
| 2 | 15.32 | 520 | 19.73 | 462 |
| 3 | 16.79 | 523 | 24.81 | 518 |
| 4 | 15.81 | 575 | 20.49 | 459 |
| 5 | 23.60 | 585 | 24.92 | 518 |
| 6 | 22.00 | 550 | 20.49 | 487 |
| 7 | 21.36 | 531 | 20.94 | 475 |
| 8 | 20.78 | 637 | 20.47 | 499 |
| 9 | 22.95 | 602 | 19.03 | 459 |
| 10 | 22.11 | 541 | 24.29 | 493 |
| 11 | 21.23 | 615 | 16.44 | 427 |
| 12 | 20.43 | 552 | 19.88 | 466 |
| 13 | 22.84 | 633 | 19.13 | 487 |
| Mean | 21.36 | 585 | 20.49 | 475 |
| Minimum | 15.32 | 520 | 16.44 | 427 |
Table 5. Freedom From Holes
| Test | Number Tested/Batch | Results |
|---|---|---|
| Tensile Strength | 13 | Pass (Minimum 16.44 MPa) |
| Ultimate Elongation | 13 | Pass (Minimum 427 %) |
| Freedom From Holes | 80 | Pass (No. Of Defective = 0) |
| No | Sample | Size | Length
(mm) | Weight of
Filter+
Dried
Residue (A) | Weight of
Filter (B) | Weight of
H20 +
Dried
Residue (C) | A-B-C
X 1000
(mg) | Residual
Powder
Content
(mg/glove) |
|----|------------------------|------|----------------|----------------------------------------------|-------------------------|--------------------------------------------|-------------------------|---------------------------------------------|
| 1 | Lot No.
81107F50510 | M | 240 | 0.0970 | 0.0945 | 0.0000 | 2.5 | 0.50 |
Table 6. Powder Residual Test Result
9
| Test Chemotherapy Drugs | Minimum Breakthrough
Detection Time
(Specimen 1/2/3) (Minutes) | Steady State Perm. Rate
(Specimen 1/2/3)
(µg/Cm2/Minute) | Other
Observations |
|---------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------------------|
| Carmustine (BCNU),
3.3 mg/ml (3,300ppm) | 54.1
(56.4, 54.1, 56.7) | 0.6
(0.6, 0.6, 0.6) | Moderate swelling
and slight
degradation |
| Cisplatin,
1.0 mg/ml (1,000 ppm) | >240 | N/A | No significant
changes |
| Cyclophosphamide
(Cytoxan), 20 mg/ml
(20,000 ppm) | >240 | N/A | No significant
changes |
| Dacarbazine,
10 mg/ml (10,000 ppm) | >240 | N/A | No significant
changes |
| Doxorubicin Hydrochloride,
2.0 mg/ml (2,000 ppm) | >240 | N/A | No significant
changes |
| Etoposide (Toposar),
20.0 mg/ml (20 000 ppm) | >240 | N/A | No significant
changes |
| Fluorouracil,
50 mg/ml (50,000ppm) | >240 | N/A | No significant
changes |
| Paclitaxel (Taxol),
6.0 mg/ml (6,000ppm) | >240 | N/A | Slight swelling
and no
degradation |
| Thiotepa (THT),
10 mg/ml (10,000ppm) | 16.0
(16.0,26.8,17.7) | 0.4
(0.5,0.3,0.4) | No significant
changes |
Table 7. Chemotherapy Drug Permeation Test Results
| Table 8. Fentanyl Drug Permeation Test Result | ||
|---|---|---|
| Test Drug And
Concentration | Minimum Breakthrough
Detection Time
(Specimen 1/2/3) (Minutes) | Steady State Perm. Rate
(Specimen 1/2/3)
(µg/Cm2/Minute) | Other
Observations |
|-------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------|------------------------------------|
| Fentanyl Citrate Injection,
100mcg/2mL | >240 | N/A | Slight swelling; no
degradation |
8. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject device, the Black Colored, Power Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under 510(K) submission K183287.