(88 days)
Not Found
No
The device is a disposable glove, and the summary focuses on its physical properties and resistance to chemical permeation, with no mention of AI or ML.
No.
The device (a nitrile examination glove) is intended to prevent contamination between patient and examiner. It does not treat or cure any medical condition.
No
This device is a glove, intended to prevent contamination between a patient and an examiner, not to diagnose a condition.
No
The device description clearly states it is a "Non-sterile, Powder-Free Nitrile Examination Glove Black," which is a physical, disposable hardware device. The summary focuses on physical properties and performance against chemical permeation, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the examiner's hand. This is a barrier function for protection, not a diagnostic test performed on a sample from the human body.
- Device Description: It's described as a "disposable device intended for medical purposes that is worn on the examiner's hand". This aligns with a protective barrier device like a glove.
- Testing: The testing described focuses on the glove's physical properties (tensile strength, elongation, dimensions, freedom from holes, powder residue) and its resistance to permeation by chemotherapy drugs and Fentanyl. These are performance characteristics of a protective barrier, not diagnostic performance metrics.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, this device is a medical glove designed for protection, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and permeation times are as follows:
Bleomycin Sulfate 15 mg/mL, >240 minutes Busulfan 6 mg/mL. >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Carmustine (BCNU) 3.3 mg/mL, 17.1 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Cytarabine 100 mg/mL, >240 minutes Dacarbazine (DTIC) 10 mg/mL, >240 minutes Daunorubicin 5 mg/mL, >240 minutes Docetaxel 10 mg/mL, >240 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Epirubicin (Ellence) 2 mg/mL. >240 minutes Etoposide (Toposar) 20 mg/mL, >240 minutes Fludarabine 25 mg/mL, >240 minutes Fluorouracil 50 mg/mL, >240 minutes Gemcitabine 38 mg/mL, >240 minutes Idarubicin 1 mg/mL, >240 minutes
Ifosfamide 50 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes Mechlorethamine 1 mg/mL, >240 minutes Melphalan 5 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 (Taxol) 6 mg/mL, >240 minutes Rituximab 10 mg/mL, >240 minutes Thiotepa 10 mg/mL, 27.9 minutes Trisenox 1 mg/mL , >240 minutes Vincristine Sulfate 1 mg/mL, >240 minutes
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL. >240 minutes
WARNING: Not for use with Carmustine or Thiotepa.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO
Device Description
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs and Fentanyl.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
Tensile strength per ASTM D 6319-10:
Before aging: Model - NOF_SD Orchid: 33; Model - NOF_SL Lilac: 34; Model - NOF_EL Oyster: 37.
After aging (70C, 168hrs.): Model - NOF_SD Orchid: 37; Model - NOF_SL Lilac: 38; Model - NOF_EL Oyster: 41.
Ultimate elongation per ASTM D 6319-10:
Before aging: Model - NOF_SD Orchid: 630; Model - NOF_SL Lilac: 570; Model - NOF_EL Oyster: 564.
After aging (70C, 168hrs.): Model - NOF_SD Orchid: 625; Model - NOF_SL Lilac: 535; Model - NOF_EL Oyster: 551.
Length (mm):
Model - NOF_SD Orchid: 240 mm; Model - NOF_SL Lilac: 238 mm; Model - NOF_EL Oyster: 240 mm.
Thickness(mm) Single wall Finger:
Model - NOF_SD Orchid: 0.14; Model - NOF_SL Lilac: 0.08; Model - NOF_EL Oyster: 0.08.
Thickness (mm) Single wall Palm:
Model - NOF_SD Orchid: 0.10; Model - NOF_SL Lilac: 0.06; Model - NOF_EL Oyster: 0.05.
Width:
Model - NOF_SD Orchid: 111; Model - NOF_SL Lilac: 110; Model - NOF_EL Oyster: 110.
Freedom from holes per ASTM D5151-2006:
Model - NOF_SD Orchid: 0; Model - NOF_SL Lilac: 1; Model - NOF_EL Oyster: 1.
Powder Residue, ASTM D6124-2006:
Model - NOF_SD Orchid: 0.5 mg/glove; Model - NOF_SL Lilac: 0.3 mg/glove; Model - NOF_EL Oyster: 0.5 mg/glove.
Resistance of Medical Gloves to Permeation by Chemotherapy Drugs per ASTM D6978:
Bleomycin Sulfate 15,000 ppm: No breakthrough up to 240 minutes for all models.
Busulfan 6,000 ppm: No breakthrough up to 240 minutes for all models.
Carboplatin 10,000 ppm: No breakthrough up to 240 minutes for all models.
Carmustine (BCNU) 3,300 ppm: Model – NOF_SD Orchid: 17.1 minutes; Model – NOF_SL Lilac: 22.8 minutes; Model – NOF_EL Oyster: 22.3 minutes. Steady State Perm. Rate: 0.4, 0.4, 0.3.
Cisplatin 1,000 ppm: No breakthrough up to 240 minutes for all models.
Cytoxan 20,000 ppm: No breakthrough up to 240 minutes for all models.
Cytarabine 100,000 ppm: No breakthrough up to 240 minutes for all models.
DTIC 10,000 ppm: No breakthrough up to 240 minutes for all models.
Daunorubicin 2,000 ppm: No breakthrough up to 240 minutes for all models.
Docetaxel 10,000 ppm: No breakthrough up to 240 minutes for all models.
Doxorubicin hydrochloride 2,000 ppm: No breakthrough up to 240 minutes for all models.
Epirubicin 2,000 ppm: No breakthrough up to 240 minutes for all models.
Etoposide (Toposar) 20,000 ppm: No breakthrough up to 240 minutes for all models.
Fludarabine 25,000 ppm: No breakthrough up to 240 minutes for all models.
Fluorouracil 50,000 ppm: No breakthrough up to 240 minutes for all models.
Gemcitabine 38,000 ppm: No breakthrough up to 240 minutes for all models.
Idarubicin 1,000 ppm: No breakthrough up to 240 minutes for all models.
Ifosfamide 50,000 ppm: No breakthrough up to 240 minutes for all models.
Irinotecan 20,000 ppm: No breakthrough up to 240 minutes for all models.
Mechlorethamine 1,000 ppm: No breakthrough up to 240 minutes for all models.
Melphalan 5,000 ppm: No breakthrough up to 240 minutes for all models.
Methotrexate 25,000 ppm: No breakthrough up to 240 minutes for all models.
Mitomycin C 500 ppm: No breakthrough up to 240 minutes for all models.
Mitoxantrone 2,000 ppm: No breakthrough up to 240 minutes for all models.
Taxol 6,000 ppm: No breakthrough up to 240 minutes for all models.
Rituximab 10,000 ppm: No breakthrough up to 240 minutes for all models.
Thiotepa 10,000 ppm: Model – NOF_SD Orchid: 27.9 minutes; Model – NOF_SL Lilac: 39.1 minutes; Model – NOF_EL Oyster: 39 minutes. Steady State Perm. Rate: 0.3, 0.3, 0.2.
Trisenox 1,000 ppm: No breakthrough up to 240 minutes for all models.
Vincristine fulfate 1,000 ppm: No breakthrough up to 240 minutes for all models.
Fentanyl Citrate 100 mcg/2mL: No breakthrough up to 240 minutes for all models.
Biocompatibility tests:
ISO 10993-10 Primary Skin Irritation in Rabbits: Under the conditions of the study, the polar and non-polar device extracts were found not to be an irritant to the animal model.
ISO 10993-5 In vitro cytotoxicity: Cytotoxic.
ISO 10993-11 Tests for systemic toxicity: the device extracts did not elicit a systemic response in the animal model.
ISO 10993-10 Guinea Pig Sensitization: Under the conditions of the study, the polar and non-polar device extracts were found not to be sensitizers to the animal model.
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
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March 20, 2020
Sri Trang Gloves (Thailand) Public Company Limited % Jordan Smith Quality Assurance and Regulatory Affairs Leader Sri Trang USA, Inc. 5820 West Cypress Street, Suite H Tampa, Florida 33607-1785
Re: K193581
Trade/Device Name: Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove
Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: November 27, 2019 Received: December 23, 2019
Dear Jordan Smith:
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 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,
For 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
2
Indications for Use
510(k) Number (if known) K193581
Device Name
Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
Indications for Use (Describe)
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs and permeation times are as follows:
Bleomycin Sulfate 15 mg/mL, >240 minutes Busulfan 6 mg/mL. >240 minutes Carboplatin (Paraplatin) 10 mg/mL, >240 minutes Carmustine (BCNU) 3.3 mg/mL, 17.1 minutes Cisplatin 1.0 mg/mL, >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Cytarabine 100 mg/mL, >240 minutes Dacarbazine (DTIC) 10 mg/mL, >240 minutes Daunorubicin 5 mg/mL, >240 minutes Docetaxel 10 mg/mL, >240 minutes Doxorubicin Hydrochloride 2 mg/mL, >240 minutes Epirubicin (Ellence) 2 mg/mL. >240 minutes Etoposide (Toposar) 20 mg/mL, >240 minutes Fludarabine 25 mg/mL, >240 minutes Fluorouracil 50 mg/mL, >240 minutes Gemcitabine 38 mg/mL, >240 minutes Idarubicin 1 mg/mL, >240 minutes
Ifosfamide 50 mg/mL, >240 minutes Irinotecan 20 mg/mL, >240 minutes Mechlorethamine 1 mg/mL, >240 minutes Melphalan 5 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 (Taxol) 6 mg/mL, >240 minutes Rituximab 10 mg/mL, >240 minutes Thiotepa 10 mg/mL, 27.9 minutes Trisenox 1 mg/mL , >240 minutes Vincristine Sulfate 1 mg/mL, >240 minutes
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL. >240 minutes
WARNING: Not for use with Carmustine or Thiotepa.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) Summary
K193581
[As Required by 21 section 807.92 (c)]
Summary prepared: March 17, 2020
A. APPLICANT INFORMATION
Submitter Name: Sri Trang Gloves (Thailand) Public Company Limited Address: 10 Soi 10 Phetkasem Rd. Hatyai Songkhla. Thailand 90110 Phone: (+66) 74 344 663 Fax: (+66) 74 344 677 Contact Person: Mr. Anan Pruksanusak, Managing Director
B. US AGENT & CONTACT PERSON INFORMATION
Official Correspondent: Sri Trang USA, Inc. Address: 5820 West Cypress Street, Suite Tampa, Florida 33607-1785 Phone: +1 (813) 606-4301 Fax: +1 (813) 606-4314 Contact person: Mr. M. Jordan Smith, Quality Assurance and Regulatory Affairs Leader
C. DEVICE IDENTIFICATION
Device Trade or Proprietary Name: Non-Sterile. Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster
Device Common or Usual Name: Examination glove
Device Classification Name: Nitrile Patient Examination Glove (21 CFR 880.6250)
Device Product Codes: LZA, LZC, QDO
Device Class: Class I
D.PREDICATE DEVICE INFORMATION
510(k) Number: K182241
Trade Name: Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs
Common Name: Examination Glove
4
Classification Name: Nitrile Patient Examination Glove Device Product Codes: LZA, LZC, QDO Device Class: Class I Regulation Number: 21 CFR 880.6250
E. DESCRIPTION OF THE DEVICE
Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs and Fentanyl.
F. INTENDED USE OF THE DEVICE
This device is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
G. Technological Characteristics Comparison Table
| TECHNOLOGICAL
CHARACTERISTICS | STANDARD | PREDICATE DEVICE
K182241 | SUBJECT DEVICE
K193581 | COMPARISON |
|----------------------------------|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | | K182241 | K193581 | |
| Trade Name | | Non-sterile, Powder-Free
Nitrile Examination
Glove Black Tested for
use with Chemotherapy
Drugs | Non-sterile, Powder Free
Nitrile Examination
Gloves | Different |
| Common Name | | Examination Glove | Examination Glove | Identical |
| Classification Name | | Nitrile Patient
Examination Glove | Nitrile Patient
Examination Glove | Identical |
| Device Product Codes | | LZA, LZC, QDO | LZA, LZC, QDO | Identical |
| Device Class | | Class I | Class I | Identical |
| Regulation Number | | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical |
| Indications for Use | N/A | This device is a
disposable device
intended for medical
purpose that is worn on
the examiner's hand to
prevent contamination
between patient and
examiner. The tested
chemotherapy drugs are
as follows: Carmustine
(BCNU) Cisplatin,
Cyclophosphamide,
Dacarbzine (DTIC),
Doxorubicin
Hydrochloride,
Etoposide (Toposar), | This device is a
disposable device
intended for medical
purpose that is worn on
the examiner's hand to
prevent contamination
between patient and
examiner.
Bleomycin Sulfate,
15mg/mL, >240 minutes
Ifosfamide 50 mg/mL,
240 minutes
Busulfan 6mg/mL, >240
minutes
Irinotecan 20 mg/mL | Similar |
5
| >240 minutes | |
|---|---|
| Carboplatin (Paraplatin) 10 mg/mL, >240 minutes | |
| Mechlorethamine 1mg/mL, >240 minutes | |
| Carmustine (BCNU) 3.3 mg/mL, 17.1 minutes, 22.8 minutes, and 22.3 minutesminutes | |
| Melphalan 5 mg/mL, >240 minutes | |
| Cisplatin 1.0 mg/mL, >240 minutes | |
| Methotrexate 25 mg/mL, >240 minutes | |
| Cyclophosphamide (Cytoxan) 20 mg/mL, | |
| Fluorouracil, | |
| Methotrexate, Paclitaxel (Taxol), Thiotepa, | |
| Vincristine Sulfate |
Note Carmustine (BCNU) and Thiotepa have low permeation times
Fentanyl tested as follows: Fentanyl Citrate | >240 minutes
Mitomycin C 0.5 mg/mL, >240 minutes
Cytarabine 100 mg/mL, >240 minutes
Mitoxantrone 2 mg/mL, >240 minutes
Dacarbazine (DTIC) 10 mg/mL, >240 minutes
Paclitaxel (Taxol) 6 mg/mL, >240 minutes
Daunorubicin 5 mg/mL, >240 minutes
Rituximab 10 mg/mL, >240 minutes
Docetazel 10 mg/mL, >240 minutes
Thiotepa 10 mg/mL, 27.9 minutes
Doxorubicin Hydrochloride 2 mg/mL, >240 minutes
Trisenox mg/mL, >240 minutes
Epirubicin (Ellence) 1 mg/mL, >240 minutes
Vincristine Sulfate 1 mg/mL, >240 minutes
Etoposide (Toposar) 20 mg/mL, >240 minutes
Fludarabine 25 mg/mL, >240 minutes
Fluorouracil 50 mg/mL, >240 minutes
Gemcitabine 38 mg/mL, >240 minutes
Idarubicin 1 mg/mL, >240 minutes
WARNING – Not for use with Carmustine and Thiotepa
Fentanyl tested as follows:
Fentanyl Citrate 100 |
6
7
| mcg/2mL, >240 minutes | ||||
|---|---|---|---|---|
| Dimensions: overall | ||||
| length | ASTM D 6319-10, | |||
| Minimum 230 mm | 238 mm | 238 mm (NOF_SL) | Similar | |
| 238 mm | 240 mm (NOF_EL) | |||
| 238 mm | 240 mm (NOF_SD) | |||
| Dimensions: width | ASTM D 6319-10, | |||
| 110 ± 10 mm | Size Large | Size Large | Similar | |
| 114 mm | 110 mm | |||
| 115 mm | 110 mm | |||
| 114 mm | 111 mm | |||
| Dimensions: palm and | ||||
| finger thickness | ASTM D 6319-10, | |||
| Minimum 0.05 mm | Palm | Palm | Similar | |
| 0.07 mm | 0.05mm (NOF_SL) | |||
| 0.07 mm | 0.05mm (NOF_EL) | |||
| 0.07 mm | 0.10 mm (NOF_SD) | |||
| Finger | Finger | |||
| 0.07 mm | 0.08 mm (NOF_SL) | |||
| 0.08 mm | 0.08 mm (NOF_EL) | |||
| 0.09 mm | 0.14 mm (NOF_SD) | |||
| Tensile strength: before | ||||
| and after aging | ASTM D 6319-10 | Before | ||
| 35 MPa | Before | |||
| 34 MPa (NOF_SL) | Similar | |||
| 33 MPa | 37 MPa (NOF_EL) | |||
| 35 MPa | 33 MPa (NOF_SD) | |||
| After | ||||
| 31 MPa | After | |||
| 38 MPa (NOF_SL) | ||||
| 32 MPa | 41 MPa (NOF_EL) | |||
| 34 MPa | 37 MPa (NOF_SD) | |||
| Ultimate elongation: | ||||
| before and after aging | ASTM D 6319-10 | Before | ||
| 538% | Before | |||
| 570 (NOF_SL) | Similar | |||
| 534% | 564% (NOF_EL) | |||
| 535% | 630% (NOF_SD) | |||
| After | ||||
| 518% | After | |||
| 535% (NOF_SL) | ||||
| 493% | 551% (NOF_EL) | |||
| 503% | 625% (NOF_SD) | |||
| Powder Free Residue | ASTM D 6319-10 | 0.7 mg/glove | 0.3 mg/glove (NOF_SL) | Similar |
| 0.8 mg/glove | 0.5 mg/glove (NOF_EL) | |||
| 0.8 mg/glove | 0.5 mg/glove (NOF_SD) | |||
| Biocompatibility | ISO 10993-10 | |||
| Primary Skin | ||||
| Irritation in Rabbits | Under the conditions of | |||
| the study, the polar and | ||||
| non- polar device | ||||
| extracts were found not | ||||
| to be an irritant to the | ||||
| animal model. | Under the conditions of | |||
| the study, the polar and | ||||
| non-polar device extracts | ||||
| were found not to be an | ||||
| irritant to the animal | ||||
| model. | Same | |||
| ISO 10993-5 | ||||
| In vitro cytotoxicity | Cytotoxic | Cytotoxic | Same | |
| ISO 10993-11 | ||||
| Tests for systemic | ||||
| toxicity | the device extracts did | |||
| not elicit a systemic | ||||
| response in the animal | ||||
| model. | the device extracts did | |||
| not elicit a systemic | ||||
| response in the animal | ||||
| model. | Same | |||
| ISO 10993-10 | ||||
| Guinea Pig | ||||
| Sensitization | Under the conditions of | |||
| the study, the polar and | ||||
| non- polar device | ||||
| extracts were found not | ||||
| to be sensitizers to the | ||||
| animal model. | Under the conditions of | |||
| the study, the polar and | ||||
| non-polar device extracts | ||||
| were found not to be | ||||
| sensitizers to the animal | ||||
| model. | Same |
8
H. Summary of Non-Clinical Performance Testings
Non-clinical tests were conducted to demonstrate that the proposed device met all design specifications. The test results demonstrated that the proposed device met the performance criteria with the following standards:
| Measurement | Standard Criteria | Subject Device Model | Results | |
|---|---|---|---|---|
| Before aging | 14 MPa Min | Tensile strength per ASTM D 6319-10 | ||
| Model - NOF_SD Orchid | 33 | |||
| Model - NOF_SL Lilac | 34 | |||
| Model - NOF_EL Oyster | 37 | |||
| After aging (70C, 168hrs.) | 14 MPa Min | Model - NOF_SD Orchid | 37 | |
| Model - NOF_SL Lilac | 38 | |||
| Model - NOF_EL Oyster | 41 | |||
| Before aging | 500% Min | Ultimate elongation per ASTM D 6319-10 | ||
| Model - NOF_SD Orchid | 630 | |||
| Model - NOF_SL Lilac | 570 | |||
| Model - NOF_EL Oyster | 564 | |||
| After aging (70C, 168hrs.) | 400% Min | Model - NOF_SD Orchid | 625 | |
| Model - NOF_SL Lilac | 535 | |||
| Model - NOF_EL Oyster | 551 | |||
| Length (mm) | 230 mm Min (M) | Model - NOF_SD Orchid | 240 mm | |
| Model - NOF_SL Lilac | 238 mm | |||
| Model - NOF_EL Oyster | 240 mm | |||
| Thickness(mm) Single | ||||
| wall Finger | 0.05 mm Min | Model - NOF_SD Orchid | 0.14 | |
| Model - NOF_SL Lilac | 0.08 | |||
| Model - NOF_EL Oyster | 0.08 | |||
| Thickness (mm) Single | ||||
| wall Palm | 0.05 mm Min | Model - NOF_SD Orchid | 0.10 | |
| Model - NOF_SL Lilac | 0.06 | |||
| Model - NOF_EL Oyster | 0.05 | |||
| Width | 110+/-10 mm (M) | Model - NOF_SD Orchid | 111 | |
| Model - NOF_SL Lilac | 110 | |||
| Model - NOF_EL Oyster | 110 | |||
| Freedom from holes per ASTM D5151-2006 | ||||
| Freedom from holes | GI, AQL 2.5 | Model - NOF_SD Orchid: 125 | 0 | |
| Accept - 7 | Model - NOF_SL Lilac: 125 | 1 | ||
| Reject - 8 | Model - NOF_EL Oyster: 125 | 1 | ||
| Powder Residue, ASTM D6124-2006 | ||||
| Powder Residue | 2.0 mg/glove | Model - NOF_SD Orchid | 0.5 mg/glove | |
| Model - NOF_SL Lilac | 0.3 mg/glove | |||
| Model - NOF_EL Oyster | 0.5 mg/glove | |||
| Resistance of Medical Gloves to Permeation by Chemotherapy Drugs per ASTM D6978 | ||||
| Test Drug and | ||||
| Concentration | Minimum Breakthrough | |||
| Detection Time Model – | ||||
| NOF_SD Orchid | Minimum Breakthrough | |||
| Detection Time Model – | ||||
| NOF_SL Lilac | Minimum Breakthrough | |||
| Detection Time Model – | ||||
| NOF_EL Oyster | Steady State | |||
| Perm. Rate | ||||
| Bleomycin | ||||
| Sulfate | ||||
| 15,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Busulfan | ||||
| 6,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Carboplatin | ||||
| 10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Carmustine | ||||
| (BCNU) | ||||
| 3,300 ppm | 17.1 minutes | 22.8 minutes | 22.3 minutes | 0.4 |
| 0.4 | ||||
| 0.3 | ||||
| Cisplatin | ||||
| 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Cytoxan | ||||
| 20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Cytarabine | ||||
| 100,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| DTIC | ||||
| 10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Daunorubicin | ||||
| 2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Docetaxel | ||||
| 10,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Doxorubicin | ||||
| hydrochloride | ||||
| 2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Epirubicin | ||||
| 2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Etoposide | ||||
| (Toposar) | ||||
| 20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Fludarabine | ||||
| 25,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Fluorouracil | ||||
| 50,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Gemcitabine | ||||
| 38,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Idarubicin | ||||
| 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Ifosfamide | ||||
| 50,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Irinotecan | ||||
| 20,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mechlorethamine | ||||
| 1,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Melphalan | ||||
| 5,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Methotrexate | ||||
| 25,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mitomycin C | ||||
| 500 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Mitoxantrone | ||||
| 2,000 ppm | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | No breakthrough up to 240 minutes | N/A |
| Taxol | ||||
| 6,000 ppm | No breakthrough up to | |||
| 240 minutes | No breakthrough up to 240 | |||
| minutes | No breakthrough up to | |||
| 240 minutes | N/A | |||
| Rituximab | ||||
| 10,000 ppm | No breakthrough | |||
| up to 240 minutes | No breakthrough | |||
| up to 240 minutes | No breakthrough | |||
| up to 240 minutes | N/A | |||
| Thiotepa 10,000 | ||||
| ppm | 27.9 minutes | 39.1 minutes | 39 minutes | 0.3 |
| 0.3 | ||||
| 0.2 | ||||
| Trisenox | ||||
| 1,000 ppm | No breakthrough up to | |||
| 240 minutes | No breakthrough up to 240 | |||
| minutes | No breakthrough up to | |||
| 240 minutes | N/A | |||
| Vincristine | ||||
| fulfate 1,000 ppm | No breakthrough up to | |||
| 240 minutes | No breakthrough up to 240 | |||
| minutes | No breakthrough up to | |||
| 240 minutes | N/A | |||
| Fentanyl Citrate | ||||
| 100 mcg/2mL | No breakthrough up to | |||
| 240 minutes | No breakthrough up to 240 | |||
| minutes | No breakthrough up to | |||
| 240 minutes | N/A |
9
10
The test results demonstrated that the proposed device complies with following standards:
ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D5151-2006 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6124-2006 (Reapproved 2001) Standard Test Method for Residual Powder on Medical Gloves
ASTM D6978 - Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
ASTM D412-2006a (reapproved 2013) 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
ISO 2859 Sampling Procedures and Tables for Inspection by Attributes
- · Tested according to ASTM D5151 for pinholes and freedom from holes, Inspection Level: GI, AQL = 2.5
- · Tested according to ASTM D6124 for powder residue, Inspection Level: N =5, AQL = N/A
- · Tested according to ASTM D412 for tensile strength and ultimate elongation before and after aging, Inspection Level: S-2, AQL 4.0
- · Tested according to ASTM D3767 for length, thickness, and width, Inspection Level: S-2. AOL 4.0
ISO 10993-5 Biological evaluation of medical devices-Part5 Tests for in vivo cytotoxicity Minimal Essential Media Elution Test:
ISO 10993-10 Biological evaluation of medical devices-Part 10 Test for irritation and delayedtype hypersensitivity
ISO 10993-11 Biological evaluation of medical devices-Part 11 Tests for systemic toxicity Acute Systemic Toxicity Test.
I. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that Non-Sterile. Powder Free Nitrile
11
Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs – Oyster are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182241.