(184 days)
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs and Fentanyl Citrate. The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The device is available in Small, Medium, Large and Extra Large sizes. The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device 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)
The provided document is a 510(k) premarket notification for "Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate." This document outlines the acceptance criteria and the results of a study to demonstrate the device's performance.
Here's the breakdown of the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides extensive tables for the performance of the gloves. Rather than recreating the entire tables found on pages 10-14, a summary of key acceptance criteria and reported performance is presented below. Please refer to pages 10-14 of the original document for the complete lists of chemotherapy drugs and specific results.
| Test Method (Standard) | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-2019 | Length of the gloves | Min 220 mm for Size Small & Min 230 mm for all other sizes | Small: 404 mmMedium: 405 mmLarge: 405 mmX-Large: 406 mm (All exceed minimums) |
| ASTM D6319-2019 | Width of the gloves | Small: 80+/-10 mm; Medium: 95+/-10 mm; Large: 110+/-10 mm; X-Large: 120+/-10 mm | Small: 84 mmMedium: 94 mmLarge: 105 mmX-Large: 115 mm (All within +/- 10mm range) |
| ASTM D6319-2019 | Thickness of the gloves | Palm 0.05 mm min; Finger 0.05 mm min for all sizes | Palm: 0.19mm (all sizes); Finger: 0.21mm (all sizes) (All exceed minimums) |
| ASTM D6319-2019 | Physical properties - Tensile strength (Before Ageing) | $\ge$ 14 Mpa for all sizes | Small: 22.77Mpa; Medium: 24.46Mpa; Large: 24.51Mpa; X-Large: 24.59Mpa (All exceed minimum) |
| ASTM D6319-2019 | Physical properties - Tensile strength (After Ageing) | $\ge$ 14 Mpa for all sizes | Small: 20.50Mpa; Medium: 21.81Mpa; Large: 21.95Mpa; X-Large: 22.05Mpa (All exceed minimum) |
| ASTM D6319-2019 | Physical properties - Ultimate Elongation (Before Ageing) | $\ge$ 500% for all sizes | Small: 885%; Medium: 888%; Large: 891%; X-Large: 892% (All exceed minimum) |
| ASTM D6319-2019 | Physical properties - Ultimate Elongation (After Ageing) | $\ge$ 400% for all sizes | Small: 868%; Medium: 870%; Large: 872%; X-Large: 875% (All exceed minimum) |
| ASTM D5151-2019 | Detection of Holes in Medical Gloves | AQL 2.5 | Passes AQL 1.5 (Better than acceptance criteria, indicating fewer defects) |
| ASTM D6124-06 | Residual Powder on Medical Gloves | 2 Mg/Glove Max | Small: 0.16 mg/glove; Medium: 0.16 mg/glove; Large: 0.16 mg/glove; X-Large: 0.16mg/glove (All meet or are below maximum) |
| ASTM D6978-05 (2019) | Permeation by Chemotherapy Drugs and Fentanyl Citrate | Specified minimum breakthrough detection times for each drug (e.g., >240 Minutes for most) | Most chemotherapy drugs and Fentanyl Citrate showed >240 Minutes breakthrough detection time.Exceptions: Carmustine (3.3 mg/ml) - 35.0 Minutes; Thiotepa (10 mg/ml) - 64.9 Minutes. Warnings are provided for these two drugs. (See pages 2-3 and 12-13 for full list and values). |
| ISO 10993-10 | Dermal Irritation (Rabbits) | Non irritant | Under the condition of study not an irritant (Meets criteria) |
| ISO 10993-10 | Skin Sensitization (Guinea Pig) | Non sensitizer | Under the conditions of the study not a sensitizer (Meets criteria) |
| ISO 10993-5:2009 | In vitro Cytotoxicity | Non cytotoxic | Under the conditions of the study cytotoxic. (Does NOT meet criteria for non-cytotoxic) |
| ISO 10993-11:2017 | Acute Systemic Toxicity | Not pose systemic toxicity concern | Under the conditions of study the device extracts do not pose acute systemic toxicity concern (Meets criteria) |
| ISO 10993-11:2017 / USP 41<151> | Material-Mediated Pyrogenicity | Not pose material mediated pyrogenicity response | Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response (Meets criteria) |
Note on Cytotoxicity: The device itself is reported as cytotoxic under the tested conditions. This is a critical finding that does not meet a "Non cytotoxic" acceptance criterion. However, the FDA has still cleared the device. This implies that either the level of cytotoxicity observed is deemed acceptable for the intended use and risk-benefit profile of examination gloves, or mitigating factors/information were provided elsewhere (not in this summary). It's important to note this discrepancy.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists various ASTM and ISO standards for testing, which define the sample sizes required for each test (e.g., AQL levels for watertightness). However, the specific quantity/sample size used for each individual test conducted by the manufacturer is not explicitly stated in this summary document beyond what's implied by the standard (e.g., AQL 1.5 for watertightness performance is a characteristic, not a sample size).
- Data Provenance: The manufacturing location of the device owner, JR Engineering & Medical Technologies (M) Sdn. Bhd., is in Malaysia (Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah 3A/1, Pusat Perindustrian 2, 44200 Rasa, Hulu Selangor, Selangor Darul Ehsan, Malaysia). The testing was conducted in accordance with international standards (ASTM, ISO), implying that the data originates from laboratory studies, likely conducted by third-party labs or the manufacturer's own qualified labs, but the specific country of the testing labs is not mentioned.
- Retrospective or Prospective: The testing described is prospective laboratory performance testing of the device, rather than a retrospective analysis of existing data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This product is a medical glove, not an AI or imaging device requiring expert consensus for ground truth. The "ground truth" for this device's performance is established through objective, standardized laboratory testing (e.g., ASTM D6319 for physical properties, ASTM D6978 for chemical permeation, ISO 10993 for biocompatibility). These tests rely on chemical and physical measurements, not human expert interpretation of images or clinical outcomes. Therefore, the concept of "number of experts used to establish ground truth" with qualifications like "radiologist with 10 years of experience" is not applicable to this type of device. The "experts" are the technicians and scientists performing the standardized validation tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not a study involving human interpretation of data where adjudication would be necessary (like in imaging diagnosis), there is no adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical examination glove, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The tests performed are "standalone" in the sense that they assess the intrinsic material properties and barrier performance of the glove itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is based on standardized, objective physical, chemical, and biological measurements obtained through laboratory testing, as defined by relevant ASTM and ISO standards. This includes:
- Physical measurements (e.g., length, width, thickness, tensile strength, elongation).
- Chemical analysis (e.g., residual powder, breakthrough detection time for drugs).
- Biological testing (e.g., irritation, sensitization, cytotoxicity, systemic toxicity, pyrogenicity).
8. The sample size for the training set
Not applicable. This device is a manufactured product (glove), not an AI algorithm or model that requires a "training set" of data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
December 7, 2022
JR Engineering & Medical Technologies (M) SDN. BHD. % Manoj Zacharias Consultant Liberty Management Group Ltd. 75 Executive Dr. Ste 114 Aurora, Illinois 60504
Re: K221626
Trade/Device Name: Jr Medic Blue Nitrile Examination Gloves Powder Free 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, OPJ, QDO Dated: November 10, 2022 Received: November 14, 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.
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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 medical devices and radiation-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 -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
Enclosure
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Indications for Use
510(k) Number (if known) K221626
Device Name
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate
Indications for Use (Describe)
Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
The tested chemotherapy drugs and their breakthrough detection times are as follows:
| Tested Chemotherapy Drug Name & Concentration | Minimum Breakthrough Detection Time |
|---|---|
| Bendamustine (5 mg/ml) | >240 Minutes |
| Bleomycin (15 mg/ml) | >240 Minutes |
| Busulfan (6 mg/ml) | >240 Minutes |
| Carfilzomib (2 mg/ml) | >240 Minutes |
| Cetuximab (2 mg/ml) | >240 Minutes |
| Cladribine (1 mg/ml) | >240 Minutes |
| Cytarabine (100 mg/ml) | >240 Minutes |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes |
| Decitabine (5 mg/ml) | >240 Minutes |
| Docetaxel (10 mg/ml) | >240 Minutes |
| Epirubicin HCl (2 mg/ml) | >240 Minutes |
| Fludarabine (25 mg/ml) | >240 Minutes |
| Fulvestrant (50 mg/ml) | >240 Minutes |
| Gemcitabine (38 mg/ml) | >240 Minutes |
| Idarubicin HCl (1 mg/ml) | >240 Minutes |
| Irinotecan (20 mg/ml) | >240 Minutes |
| Mechlorethamine (1 mg/ml) | >240 Minutes |
| Melphalan (5 mg/ml) | >240 Minutes |
| Oxaliplatin (5 mg/ml) | >240 Minutes |
| Paraplatin (10 mg/ml) | >240 Minutes |
| Pemetrexed (25 mg/ml) | >240 Minutes |
| Raltitrexed (0.5 mg/ml) | >240 Minutes |
| Rituximab (10 mg/ml) | >240 Minutes |
| Topotecan (1 mg/ml) | >240 Minutes |
| Triclosan (2 mg/ml) | >240 Minutes |
| Trisenox (1 mg/ml) | >240 Minutes |
| Velcade (Bortezomib) (1 mg/ml) | >240 Minutes |
| Vidaza (Azacytidine) (25 mg/ml) | >240 Minutes |
| Vinblastine (1 mg/ml) | >240 Minutes |
| Vinorelbine (10 mg/ml) | >240 Minutes |
| Carmustine (BCNU) (3.3 mg/ml) | 35.0 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
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| Cisplatin (1 mg/ml) | >240 Minutes |
|---|---|
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 64.9 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
The following hazardous drugs (opioid) and concentration had no breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2ml)
Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes Thiotepa (10 mg/ml) 64.9 Minutes
Warning: Do not use with Carmustine or Thiotepa.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
区 Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY K221626 As required by: 21CFR§807.92(c)
A. APPLICANTINFORMATION
| 510(K) Owner's Name | JR Engineering & Medical Technologies (M) Sdn. Bhd. |
|---|---|
| Address | Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah 3A/1,Pusat Perindustrian 2, 44200 Rasa, Hulu Selangor, SelangorDarul Ehsan, Malaysia. |
| Phone | +603-60572081 |
| Fax | +603-60572181 |
| ganeshjrmt@gmail.com | |
| Contact Person | Mr. Ganesan Subramaniam |
| Designation | Managing Director |
| Contact Number | +6012 224 6677 |
| Contact Email | ganeshjrmt@gmail.com |
| Date Submitted | 10th November 2022 |
B. DEVICE IDENTIFICATION
| Name of the device | Jr Medic Blue Nitrile Examination Gloves Powder Freetested for use with Chemotherapy drugs and FentanylCitrate |
|---|---|
| Product proprietary or trade name | JR MEDIC |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves, Specialty &Fentanyl and other opioid protection glove |
| Device Classification | Class-1 |
| Product Code | LZA, LZC, QDO, OPJ |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Halyard Lavender Nitrile, Powder-free Exam GlovesTested for use with Chemotherapy Drugs and FentanylCitrate |
|---|---|
| 510(K) Number | K202622 |
| Regulatory Class | 1 |
| Product code | LZC, QDO |
D. DESCRIPTION OF THEDEVICE:
The subject device in 510(K) notification is a blue nitrile examination gloves powder free tested for use with Chemotherapy drugs and Fentanyl Citrate.
The subject device is a patient examination glove made from acrylonitrile-butadiene copolymer dispersion, blue color, powder free and non sterile (as per 21CFR 880.6250, class I). The device is
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available in Small, Medium, Large and Extra Large sizes.
The subject device meets all the current specifications listed under the ASTM Specification D 6319 -2019, Standard Specification for Nitrile Examination Gloves for Medical Application. This device 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)
E. INTENDED USE OF THE DEVICE/INDICATIONS FOR USE:
Ir Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. Additionally, the gloves were tested for use with chemotherapy drugs and Fentanyl Citrate in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs.
| Tested Chemotherapy Drug Name & | Minimum Breakthrough Detection |
|---|---|
| Concentration | Time (Minutes) |
| Bendamustine (5 mg/ml) | >240 Minutes |
| Bleomycin (15 mg/ml) | >240 Minutes |
| Busulfan (6 mg/ml) | >240 Minutes |
| Carfilzomib (2 mg/ml) | >240 Minutes |
| Cetuximab (2 mg/ml) | >240 Minutes |
| Cladribine (1 mg/ml) | >240 Minutes |
| Cytarabine (100 mg/ml) | >240 Minutes |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes |
| Decitabine (5 mg/ml) | >240 Minutes |
| Docetaxel (10 mg/ml) | >240 Minutes |
| Epirubicin HCl (2 mg/ml) | >240 Minutes |
| Fludarabine (25 mg/ml) | >240 Minutes |
| Fulvestrant (50 mg/ml) | >240 Minutes |
| Gemcitabine (38 mg/ml) | >240 Minutes |
| Idarubicin HCl (1 mg/ml) | >240 Minutes |
| Irinotecan (20 mg/ml) | >240 Minutes |
| Mechlorethamine (1 mg/ml) | >240 Minutes |
| Melphalan (5 mg/ml) | >240 Minutes |
| Oxaliplatin (5 mg/ml) | >240 Minutes |
| Paraplatin (10 mg/ml) | >240 Minutes |
| Pemetrexed (25 mg/ml) | >240 Minutes |
| Raltitrexed (0.5 mg/ml) | >240 Minutes |
| Rituximab (10 mg/ml) | >240 Minutes |
| Topotecan (1 mg/ml) | >240 Minutes |
| Triclosan (2 mg/ml) | >240 Minutes |
| Trisenox (1 mg/ml) | >240 Minutes |
| Velcade (Bortezomib) (1 mg/ml) | >240 Minutes |
| Vidaza (Azacytidine) (25 mg/ml) | >240 Minutes |
The tested chemotherapy drugs and their breakthrough detection times are as follows:
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| Vinblastine (1 mg/ml) | >240 Minutes |
|---|---|
| Vinorelbine (10 mg/ml) | >240 Minutes |
| Carmustine (BCNU) (3.3 mg/ml) | 35.0 Minutes |
| Carboplatin (10 mg/ml) | >240 Minutes |
| Cisplatin (1 mg/ml) | >240 Minutes |
| Cyclophosphamide (Cytoxan) (20 mg/ml) | >240 Minutes |
| Dacarbazine (10.0 mg/ml) | >240 Minutes |
| Doxorubicin HCl (2 mg/ml) | >240 Minutes |
| Etoposide (20 mg/ml) | >240 Minutes |
| Fluorouracil (50 mg/ml) | >240 Minutes |
| Ifosfamide (50 mg/ml) | >240 Minutes |
| Methotrexate (25 mg/ml) | >240 Minutes |
| Mitomycin C (0.5 mg/ml) | >240 Minutes |
| Mitoxantrone (2 mg/ml) | >240 Minutes |
| Paclitaxel (6 mg/ml) | >240 Minutes |
| Thiotepa (10 mg/ml) | 64.9 Minutes |
| Vincristine Sulfate (1 mg/ml) | >240 Minutes |
The following hazardous drugs (opioid) and concentration had no breakthrough detected up to 240 minutes: Fentanyl Citrate Injection (100 mcg/2ml)
Please note that the following drugs have low permeation times: Carmustine (BCNU) (3.3 mg/ml) 35.0 Minutes Thiotepa (10 mg/ml) 64.9 Minutes
Warning: Do not use with Carmustine (BCNU) & Thiotepa
F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | |
|---|---|---|---|---|
| PREDICATE | PROPOSED DEVICE | |||
| 510(K) Number | - | K202622 | K221626 | |
| Name of device | Halyard LavenderNitrile, Powder-free Exam GlovesTested for usewithChemotherapyDrugs andFentanyl Citrate | Jr MedicBlue NitrileExamination GlovesPowder Free testedfor use withChemotherapy drugsand Fentanyl Citrate | Similar | |
| Product Code | - | LZA, LZC, QDO | LZA, LZC, QDO, OPJ | Similar |
| Intended use /Indications for Use | The HalyardLavender Nitrile,Powder-free ExamGlovesTested for usewithChemotherapyDrugs and | Jr Medic Blue NitrileExamination GlovesPowder Free testedfor use withChemotherapy drugsand Fentanyl Citrateis a disposable deviceintended for medical | Similar |
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| Fentanyl Citrateare disposable | purpose that is wornon the examiner's | |||
|---|---|---|---|---|
| -- | -- | ------------------------------------ | ------------------------------------------- | -- |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | |
|---|---|---|---|---|
| PREDICATEK202622 | PROPOSEDDEVICE | |||
| device intendedfor medicalpurpose that isworn on theexaminer's handto preventcontaminationbetween patientand examiner.The gloves weretested for usewith thechemotherapydrugs andFentanyl Citrateas per ASTM D6978-05 | hand to preventcontaminationbetween patientand examiner.Additionally, thegloves were testedfor use withchemotherapydrugs andFentanyl Citrate inaccordance withASTM D6978-05(2019) StandardPractice forAssessment ofMedical Glove toPermeation byChemotherapyDrugs. | |||
| Regulation Number | - | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | - | Nitrile | Nitrile | Same |
| Color | - | Lavender | Blue | Different |
| Size | ASTM D6319-2019 | Extra Small,Small, Medium,Large, Extra Large | Small, Medium,Large, Extra Large | Similar |
| Single Use | Medical GloveGuidanceManual- Labeling | Single Use | Single Use | Same |
| Sterile/non sterile | - | Non sterile | Non sterile | Same |
| Dimensions | ASTM D6319-2019 | Length:295-325 mmWidthXS- 60-80mmS- 70-90mmM- 85-105mmL- 100-120mmXL- 110-130mm | Length > 230 mmWidth Min 95+/-10 mm(formedium size) | Similar |
| CHARACTERSTICS | STANDARDS | DEVICE PERFORMANCE | REMARKS | |
| PREDICATE DEVICEK202622 | PROPOSED DEVICEK221626 | |||
| PhysicalProperties | ASTM D6319-2019 | Before AgeingTensile Strength$\ge$ 14 MpaUltimate Elongation$\ge$ 500%After AgeingTensile Strength$\ge$ 14 MpaUltimate Elongation$\ge$ 400% | Before AgeingTensile Strength> 14 MpaUltimate Elongation>500%After AgeingTensile Strength>14 MpaUltimate Elongation> 400% | Similar |
| Thickness | ASTM D6319-2019 | Palm0.10-0.16 mmFinger0.10-0.19 mm | Palm >0.05 mmFinger > 0.05 mm | Similar |
| Powder FreeResidue | ASTM D6319-2019 | $\le$ 2 mg/glove | $\le$ 2 mg/glove | Similar |
| Watertight(1000 ml) | ASTM D5151-2019 | Passes AQL-2.5 | Passes AQL-1.5 | Similar |
| Label andLabeling | FDA Labelrequirements | Meets FDA'srequirements | Meets FDA'srequirements | Same |
| Bio-compatibility | Primary SkinIrritation-ISO 10993-10:2010(E) | Under the condition ofstudy the deviceextracts were not foundto cause a systemicresponse in the animalmodel. | Under the conditionof study not anirritant | Similar |
| Dermal Sensitization-ISO 10993-10:2010(E) | No Data Available | Under the conditionsof the study not asensitizer | ---- | |
| In vitrocytotoxicityISO10993-5 :2009(E) | No Data Available | Under theconditions of thestudy, cytotoxic | ---- | |
| MaterialMediatedPyrogenicityISO 10993-11:2017(E) /USP 41<151> | No Data Available | Under theconditions ofthe study nomaterial-mediatedpyrogenic | ---- | |
| Acute SystemicToxicity Test ISO10993-11:2017(E) | Under the conditions ofthe study, the testarticle was considerednon toxic | Under the conditionof study does notinduce any systemictoxic concern | Similar |
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| Chemotherapy Drugs tested with Minimum Breakthrough Detection Time as tested per ASTM | ||||
|---|---|---|---|---|
| D6978-05 (2019) | ||||
| Bendamustine (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Bleomycin (15 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Busulfan (6 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Carfilzomib (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cetuximab (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cladribine (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cytarabine (100 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Decitabine (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Docetaxel (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Epirubicin HCl (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Fludarabine (25 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Fulvestrant (50 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Gemcitabine (38 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Idarubicin HCl (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Irinotecan (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Mechlorethamine (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Melphalan (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Oxaliplatin (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Paraplatin (10 mg/ml) | Not Tested | >240 Minutes | Different | |
| Pemetrexed (25 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Raltitrexed (0.5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Rituximab (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Topotecan (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Triclosan (2 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Trisenox (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Velcade (Bortezomib) (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Vidaza (Azacytidine) (25 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Vinblastine (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Vinorelbine (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Capecitabine (26 mg/ml) | >240 Minutes | Not Tested | Different | |
| Carboplatin (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cisplatin (1 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Cyclophosphamide (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Dacarbazine (10 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Dactinomycin (0.5 mg/ml) | >240 Minutes | Not Tested | Different | |
| Doxorubicin HCl (5 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| Etoposide (20 mg/ml) | >240 Minutes | >240 Minutes | Same | |
| 5-Fluorouracil (50 mg/ml) | >240 Minutes | >240 Minutes | Same |
{10}------------------------------------------------
| Ifosfamide (50 mg/ml) | >240 Minutes | >240 Minutes | Same |
|---|---|---|---|
| Leuprolide Acetate Salt ( 5mg/ml) | >240 Minutes | Not Tested | Different |
| Methotrexate (25 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Mitoxantrone (2 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Paclitaxel (6 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Temsirolimus (25 mg/ml) | >240 Minutes | Not Tested | Different |
| Vincristine (1 mg/ml) | >240 Minutes | >240 Minutes | Same |
| Zoledronic Acid (0.8 mg/ml) | >240 Minutes | Not Tested | Different |
| Carmustine (3.3 mg/ml) | 0.3 Minutes | 35.0 Minutes | Different |
| Thiotepa (10 mg/ml) | 30.9 Minutes | 64.9 Minutes | Different |
Hazardous Drugs (opioid) tested with Minimum Breakthrough Detection Time as tested per ASTM D6978-05 (2019)
| Fentanyl Citrate (100 mg/ml) | >240 Minutes | >240 Minutes | Same |
|---|---|---|---|
| ------------------------------ | -------------- | -------------- | ------ |
There are no significant differences between the proposed device and the predicate device and are identical in terms of intended use, materials, design, manufacturing methods & resistance of medical gloves to permeation by chemotherapy drugs and Fentanyl Citrate as per ASTM D6978- 05(2019).
G. NON-CLINICAL TESTING SUMMARY PERFORMANCE DATA
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| ASTM D6319-2019Standard Specification forNitrile Examination Glovesfor Medical Application | To determine the lengthof the gloves | Min 220 mm for SizeSmall & Min 230 mmfor all other sizes | Small:- 404 mmMedium:- 405 mmLarge:- 405 mmX-Large:- 406 mm |
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| Test Method | Purpose | Acceptance Criteria | Result | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thewidth of the gloves | Small:- $80+/-10$ mmMedium:- $95+/-10$ mmLarge:- $110+/-10$ mmX-Large:- $120+/10$ mm | Small:- 84 mmMedium:- 94 mmLarge:- 105 mmX-Large:- 115 mm | |||||||||||||||
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To determine thethickness of thegloves | Palm 0.05 mm minFinger 0.05 mm minfor all sizes | Size Palm Finger Small 0.19mm 0.21mm Medium 0.19mm 0.21mm Large 0.19mm 0.21mm X-Large 0.19mm 0.21mm | |||||||||||||||
| To Determine thephysical properties-Tensile strength | Before AgeingTensile Strength14Mpa Min for allsizes | Size Beforeageing Afterageing Small 22.77Mpa 20.50Mpa Medium 24.46Mpa 21.81Mpa Large 24.51Mpa 21.95Mpa X-Large 24.59Mpa 22.05Mpa | ||||||||||||||||
| After Ageing TensileStrength 14Mpa Minfor all sizes | ||||||||||||||||||
| ASTM D6319-2019 StandardSpecification for NitrileExamination Gloves forMedical Application | To Determine thephysical properties-Ultimate Elongation | Before AgeingUltimate Elongation500% Min for allsizes | Size Beforeageing Afterageing Small 885% 868% Medium 888% 870% Large 891% 872% X-Large 892% 875% | |||||||||||||||
| After AgeingUltimate Elongation400% Min for allsizes |
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ASTM D5151-2019 StandardTest Method for Detection ofHoles in Medical Gloves | To determine theholes in the gloves | AQL 2.5 | Gloves Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved2017) Standard Test Methodfor Residual Powder onMedical Gloves | To determine theresidual powder inthe gloves | 2 Mg/Glove Max | SizeSmall 0.16 mg/gloveMedium 0.16 mg/gloveLarge 0.16 mg/gloveX-Large 0.16mg/glove |
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PERMEATION TEST RESULT AS PER ASTM D6978
| Test Chemotherapy Drugs | MinimumBreakthroughDetection Time(Minutes) | Avg. SteadyStatePerm. Rate(µg/cm²/Minute) | Other Observations |
|---|---|---|---|
| Bendamustine (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Bleomycin (15 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Busulfan (6 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Carfilzomib (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cetuximab (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cladribine (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cytarabine (100 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Daunorubicin HCl (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Decitabine (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Docetaxel (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Epirubicin HCl (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Fludarabine (25 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Fulvestrant (50 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Gemcitabine (38 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Idarubicin HCl (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Irinotecan (20 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Mechlorethamine (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Melphalan (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Oxaliplatin (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Paraplatin (10 mg/ml) | Not Tested | NA | Slight swelling & no degradation |
| Pemetrexed (25 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Raltitrexed (0.5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Rituximab (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Topotecan (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Triclosan (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Trisenox (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Velcade (Bortezomib)(1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Vidaza (Azacytidine)(25 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Vinblastine (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Vinorelbine (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Carboplatin (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cisplatin (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Cyclophosphamide (20 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Dacarbazine (10 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Doxorubicin HCl (5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Etoposide (20 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| 5-Fluorouracil (50 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Ifosfamide (50 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Test Chemotherapy Drugs | MinimumBreakthroughDetection Time(Minutes) | Avg. SteadyStatePerm. Rate(µg/cm²/Minute) | Other Observations |
| Methotrexate (25 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Mitomycin C (0.5 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Mitoxantrone (2 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Paclitaxel (6 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Vincristine (1 mg/ml) | >240 Minutes | NA | Slight swelling & no degradation |
| Carmustine (3.3 mg/ml) | 35.0 Minutes | NA | Slight swelling & no degradation |
| Thiotepa (10 mg/ml) | 64.9 Minutes | NA | Slight swelling & no degradation |
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H. NON- CLINICAL TESTING BIO-COMPATABILITY DATA
| Test Method | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done forirritation. | To determine the potential ofthe material under test toproduce dermal irritation inRabbits | Non irritant | Under the condition ofstudy not an irritant |
| ISO 10993-10 BiologicalEvaluation of Medical DevicesTest for Irritation and SkinSensitization. Test done Skinsensitization. | To determine the skinsensitization potential of thematerial both in terms ofinduction and elicitation inGuinea Pig. | Non sensitizer | Under the conditions ofthe study not asensitizer |
| ISO 10993-5:2009 biologicalevaluation of medical devices -part 5, tests for in vitrocytotoxicity. | To evaluate the in vitrocytotoxic potential of the testitem (both inner and outersurface) Extracts in L-929mouse fibroblasts cells usingelution method. | Non cytotoxic | Under the conditions ofthe study cytotoxic. |
| ISO 10993-11:2017 biologicalevaluation of medical devices -part 11, tests for systemictoxicity. | To determine the acutesystemic toxicity potential ofthe test item extracts (bothinside and outer surfaces) inSwiss Albino mice. | Not pose systemictoxicity concern | Under the conditionsof study the deviceextracts do not poseacute systemictoxicity concern |
| MaterialMediatedPyrogenicity ISO 10993-11:2017(E) / USP 41<151> | To determine the pyrogenicpotential of the test itemextract following intravenousinjection in New Zealandwhite Rabbits. | Not pose materialmediatedpyrogenicityresponse | Under the conditions ofthe study, the device didnot demonstrate amaterial mediatedpyrogenicity response. |
{14}------------------------------------------------
I. Clinical Testing Summary
No clinical information is included in this submission
J. CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.
§ 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.