(72 days)
Not Found
No
The device description and performance studies focus on the physical properties and chemical resistance of examination gloves, with no mention of AI or ML.
No.
The device is described as a disposable glove intended to prevent contamination between a patient and an examiner. It does not provide any therapeutic effect to the patient.
No.
The device described is a medical glove, intended to prevent contamination between patient and examiner. It does not provide any diagnostic information or aid in identifying diseases or conditions.
No
The device description clearly states it is a physical product (gloves) made of nitrile, with specific physical characteristics and performance testing related to material properties and barrier function. There is no mention of software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection during medical examinations or procedures.
- Device Description: The description reinforces this by stating the gloves are "intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner."
- Lack of Diagnostic Purpose: An IVD is a device intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This glove does not perform any such examination or provide diagnostic information. Its function is purely protective.
- Testing for Chemotherapy Drugs and Fentanyl: While the gloves are tested for resistance to these substances, this testing relates to the protective barrier function of the glove, not to any diagnostic capability.
Therefore, this device falls under the category of a medical device used for protection and contamination prevention, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl, 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 are:
Carmustine ( 3.3mg/mL 3,300 ppm) 11.1 min
Cisplatin ( 1.0 mg/mL 1,000 ppm) >240 min
Cyclophosphamide (20 mg/mL 20,000 ppm) >240 min
Cytarabine (Cytosine) (100 mg/mL 100,000 ppm) >240 min
Dacarbazine (10 mg/mL 10,000 ppm) >240 min
Doxorubicin (Adriamycin) (2.0 mg/mL 2,000 ppm) >240 min
Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min
Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min
Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min
Methotrexate (25.0 mg/mL 25,000 ppm) >240 min
Mitomycin C (0.5 mg/mL 500 ppm) >240 min
Mitoxantrone HCL (2.0 mg/mL 2,000 ppm >240 min
Paclitaxel (6.0 mg/mL 6,000 ppm) >240 min
Thiotepa (10.0 mg/mL 10.000 ppm) 34.8 min
Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min
Fentanyl Citrate Injection (100 mcg/2mL) >240 min
Note: Carmustine and Thiotepa have extremely low permeation times of 11.1 and 34.8 minutes respectively. Warning: Do Not Use with Carmustine. Thiotepa
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, QDO
Device Description
The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in five sizes, extra small, small, medium, large, and extra-large, packed in a paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
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 Testing:
- Biocompatibility Testing: Conducted according to ISO 10993-1:2018 for Surface Device category, Skin Contact, and duration of contact Limited (≤24h). Tests conducted: ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-23 (Primary Skin Irritation), ISO 10993-10 (Dermal Sensitization), ISO 10993-11 (Acute Systemic Toxicity).
- Results: Not an irritant, not a sensitizer. For In Vitro Cytotoxicity, test article extract showed potential toxicity. For Acute Systemic Toxicity, device extract does not induce acute systemic toxicity response.
- Performance Testing: Conducted as per ASTM D6319-19 and ASTM D6978.
- Dimensions (width, thickness) per ASTM D6319-19: Length (XS, S: min 220mm; M, L, XL: min 230mm), Width (XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm), Palm thickness (min 0.05mm), Finger thickness (min 0.05mm). Results: Pass for all dimensions.
- Physical properties (tensile strength, ultimate elongation) per ASTM D6319-19: Before aging (Tensile Strength: >= 14 MPa, Ultimate Elongation: >= 500%), After aging (Tensile Strength: >= 14 MPa, Ultimate Elongation: >= 400%). Results: Pass for all physical properties.
- Freedom from holes per ASTM D5151-19: No leakage at sampling level of G-1, AQL 2.5. Results: Pass.
- Residual Powder per ASTM D6124-06 (Reapproved 2017): 240 min
- Cyclophosphamide (20 mg/mL 20,000 ppm): >240 min
- Cytarabine (Cytosine) (100 mg/mL 100,000 ppm): >240 min
- Dacarbazine (10 mg/mL 10,000 ppm): >240 min
- Doxorubicin (Adriamycin) (2.0 mg/mL 2,000 ppm): >240 min
- Etoposide (Toposar) (20.0 mg/mL 20,000 ppm): >240 min
- Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm): >240 min
- Ifosfamide (50.0 mg/mL 50,000 ppm): >240 min
- Methotrexate (25.0 mg/mL 25,000 ppm): >240 min
- Mitomycin C (0.5 mg/mL 500 ppm): >240 min
- Mitoxantrone HCL (2.0 mg/mL 2,000 ppm): >240 min
- Paclitaxel (6.0 mg/mL 6,000 ppm): >240 min
- Thiotepa (10.0 mg/mL 10,000 ppm): 34.8 min
- Vincristine Sulfate (1.0 mg/mL 1,000 ppm): >240 min
- Fentanyl Citrate Injection (100 mcg/2mL): >240 min
- Results: Pass.
No clinical study is included in this submission.
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
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 12, 2024
Anhui Powerguard Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K233520
Trade/Device Name: Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl 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 1, 2023 Received: November 1, 2023
Dear Ivy Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
llan v
For Bifeng Qian, M.D., Ph.D. Assistant Director
2
DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233520
Device Name
Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl
Indications for Use (Describe)
The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentany1, 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 are: Chemotherapy drug Concentration Minimum Breakthrough Detection Time Carmustine ( 3.3mg/mL 3,300 ppm) 11.1 min Cisplatin ( 1.0 mg/mL 1,000 ppm) >240 min Cyclophosphamide (20 mg/mL 20,000 ppm) >240 min Cytarabine (Cytosine) (100 mg/mL 100,000 ppm) >240 min Dacarbazine (10 mg/mL 10,000 ppm) >240 min Doxorubicin (Adriamycin) (2.0 mg/mL 2,000 ppm) >240 min Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) >240 min Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) >240 min Ifosfamide (50.0 mg/mL 50,000 ppm) >240 min Methotrexate (25.0 mg/mL 25,000 ppm) >240 min Mitomycin C (0.5 mg/mL 500 ppm) >240 min Mitoxantrone HCL (2.0 mg/mL 2,000 ppm >240 min Paclitaxel (6.0 mg/mL 6,000 ppm) >240 min Thiotepa (10.0 mg/mL 10.000 ppm) 34.8 min Vincristine Sulfate (1.0 mg/mL 1,000 ppm >240 min Fentanyl Citrate Injection (100 mcg/2mL) >240 min Note: Carmustine and Thiotepa have extremely low permeation times of 11.1 and 34.8 minutes respectively. Warning: Do Not Use with Carmustine. Thiotepa
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) Summary
K233520
(As required by 21 CFR 807.92)
Date prepared: 2024-01-12
A. Applicant:
Name: Anhui Powerguard Technology Co., Ltd. Address: Lingbi North Development Zone, Suzhou City, Anhui Province, China Contact: Mr. Nick Dai Title: Vice General Manager Tel: +86-13851555057 Email: nick.dai@powerguard.cc
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: zxfda@sungoglobal.com
B. Device:
Trade Name: Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl Common Name: Nitrile Patient Examination Gloves (Powder Free) Size(s): XS, S, M, L, XL
Regulatory Information
Classification Name: Polymer Patient Examination Glove Classification: Class I Product code: LZA, LZC, OPJ, QDO Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
C. Predicate device:
K223903 Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SEMPERIT INVESTMENTS ASIA PTE. LTD.
D. Indications for use of the device:
The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and
5
Fentanyl, 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 are:
| Chemotherapy drug | Concentration | Minimum Breakthrough Detection Time |
|---|---|---|
| Carmustine | (3.3mg/mL 3,300 ppm) | 11.1 min |
| Cisplatin | (1.0 mg/mL 1,000 ppm) | >240 min |
| Cyclophosphamide | (20 mg/mL 20,000 ppm) | >240 min |
| Cytarabine (Cytosine) | (100 mg/mL 100,000 ppm) | >240 min |
| Dacarbazine | (10 mg/mL 10,000 ppm) | >240 min |
| Doxorubicin (Adriamycin) | (2.0 mg/mL 2,000 ppm) | >240 min |
| Etoposide (Toposar) | (20.0 mg/mL 20,000 ppm) | >240 min |
| Fluorouracil (5 Flu) | (50.0 mg/mL 50,000 ppm) | >240 min |
| Ifosfamide | (50.0 mg/mL 50,000 ppm) | >240 min |
| Methotrexate | (25.0 mg/mL 25,000 ppm) | >240 min |
| Mitomycin C | (0.5 mg/mL 500 ppm) | >240 min |
| Mitoxantrone HCL | (2.0 mg/mL 2,000 ppm) | >240 min |
| Paclitaxel | (6.0 mg/mL 6,000 ppm) | >240 min |
| Thiotepa | (10.0 mg/mL 10,000 ppm) | 34.8 min |
| Vincristine Sulfate | (1.0 mg/mL 1,000 ppm) | >240 min |
| Fentanyl Citrate Injection | (100 mcg/2mL) | >240 min |
Note: Carmustine and Thiotepa have extremely low permeation times of 11.1 and 34.8 minutes respectively. Warning: Do Not Use with Carmustine, Thiotepa
E. Device Description:
The Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl are non-sterile, single use only, disposable examination gloves intended for medical purposes to be worn by examiners to prevent contamination between the patient and the examiner. The gloves are blue color, powder free, nitrile ambidextrous gloves are offered in five sizes, extra small, small, medium, large, and extra-large, packed in a paper box.
The gloves are designed and manufactured in accordance with the ASTM D6319 standard and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
F. Summary of Technological Characteristics
Table 1 General Comparison of Proposed and Predicate Devices
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| -------- | ----------------- | ------------------ | -------- |
6
| 510K # | K223903 | - | |
|---|---|---|---|
| Product Name | Powder free, Non-sterile, Blue Nitrile | ||
| Examination Gloves, Tested for Use with | |||
| Chemotherapy Drugs and Fentanyl | Non-Sterile, Single use, Powder-free | ||
| examination glove, Blue, tested for | |||
| use with Chemotherapy drugs and | |||
| Fentanyl | - | ||
| Product Code | LZA (primary), LZC, OPJ, QDO | LZA (primary), LZC, OPJ, QDO | Same |
| Classification | Class I | Class I | Same |
| Regulation | |||
| Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for | |||
| use | The Powder free, Non-sterile, Blue Nitrile | ||
| Examination Glove, Tested for Use with | |||
| Chemotherapy Drugs and Fentanyl, 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 are: | |||
| Chemotherapy drug Concentration Minimum | |||
| Breakthrough Detection Time | |||
| Carmustine (3.3mg/mL 3,300 ppm) 11.1 | |||
| Cisplatin (1.0 mg/mL 1,000 ppm) >240 min | |||
| Cyclophosphamide (20 mg/mL 20,000 ppm) |
240 min
Cytarabine (Cytosine) (100 mg/mL 100,000
ppm) >240 min
Dacarbazine (10 mg/mL 10,000 ppm) >
240 min
Doxorubicin (Adriamycin) (2.0 mg/mL 2,000
ppm) >240 min
Etoposide (Toposar) (20.0 mg/mL 20,000
ppm) >240 min
Fluorouracil (5 Flu) (50.0 mg/mL 50,000
ppm) >240 min
Ifosfamide (50.0 mg/mL 50,000 ppm) >
240 min
Methotrexate (25.0 mg/mL 25,000 ppm)
240 min
Mitomycin C (0.5 mg/mL 500 ppm) >240
min
Mitoxantrone HCL (2.0 mg/mL 2,000 ppm >
240 min
Paclitaxel (6.0 mg/mL 6,000 ppm) >240
min | This device is an ambidextrous patient
examination glove that is a non-sterile,
single use, disposable device intended
for medical purposes, worn on the
examiner's hand or finger to prevent
contamination between patient and
examiner.
The tested chemotherapy drugs are:
Carmustine (BCNU) (3.3 mg/ml).
Permeation time: Carmustine (BCNU)
has extremely low permeation times of
14.7 minutes.
Cisplatin (1.0 mg/ml). Permeation time:
no breakthrough up to 240 minutes
Cyclophosphamide (Cytoxan) (20.0 mg/
ml). Permeation time: no breakthrough
up to 240 minutes
Cytarabine (100 mg/ml). Permeation
time: no breakthrough
up to 240 minutes Dacarbazine (DTIC)
(10.0 mg/ml). Permeation time: no
breakthrough up to 240 minutes
Doxorubicin Hydrochloride (2.0 mg/ml).
Permeation time: no breakthrough up to
240 minutes
Etoposide (20.0 mg/ml). Permeation
time: no breakthrough up to 240
minutes
Fluorouracil (50.0 mg/ml).
Permeation time: no breakthrough up to
240 minutes
Ifosfamide (50.0 mg/ml). Permeation
time: no breakthrough up to 240
minutes | Similar |
| | Thiotepa (10.0 mg/mL 10,000 ppm) 34.8 | Methotrexate (25.0 | |
| | Vincristine Sulfate (1.0 mg/mL 1,000 ppm | mg/ml). Permeation time: no | |
| | >240 min | breakthrough up to 240 minutes | |
| | Fentanyl Citrate Injection (100 mcg/2mL) > | Mitomycin C (0.5 mg/ml). Permeation | |
| | 240 min | time: no breakthrough up to 240 | |
| | Note: Carmustine and Thiotepa have | minutes | |
| | extremely low permeation times of 11.1 and | Mitoxantrone (2.0 mg/ml). | |
| | 34.8 minutes respectively. | Permeation time: no breakthrough up to | |
| | Warning: Do Not Use with Carmustine, | 240 minutes Paclitaxel (Taxol) (6.0 | |
| | Thiotepa | mg/ml). Permeation time: no | |
| | | breakthrough up to 240 minutes | |
| | | Thiotepa (10.0 mg/ml). Permeation | |
| | | time: Thiotepa has extremely low | |
| | | permeation times of 13.6 minutes | |
| | | Vincristine Sulfate (1.0 mg/ml). | |
| | | Permeation time: no Breakthrough up | |
| | | to 240 minutes. | |
| | | The tested Opiod is: | |
| | | Fentanyl Citrate Injection | |
| | | (100mcg/2mL). Permeation: no | |
| | | breakthrough up to 240 minutes | |
| | | Please note that the following drugs | |
| | | have extremely low permeation times: | |
| | | Carmustine: 14.7 minutes | |
| | | Thiotepa: 13.6 minutes | |
| | | Warning: DO NOT USE WITH | |
| | | CARMUSTINE OR THIOTEPA | |
| Powder free | Yes | Yes | Same |
| Design feature | Ambidextrous | Ambidextrous | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Singe use | Single use | Same |
| Labeling claim | Tested for Use with Chemotherapy Drugs
and Fentanyl | Tested for Use with Chemotherapy Drugs
and Fentanyl | Same |
7
Analysis: The proposed device and the predicate device have same indications, only minor differences on the penetration time of carmustine and thiotepa between the proposed device and the predicate device, which will not raise any new safety or performance concerns.
| Technological characteristics | Proposed Device | Predicate Device (K223903) | Result |
|---|---|---|---|
| Length | |||
| XS, S | Minimum 220mm | Minimum 220mm | Same |
8
| M, L, XL | Minimum 230mm | Minimum 230mm | Same |
|---|---|---|---|
| Palm width (size) (mm) | |||
| XS | $70\pm10$ | $70\pm10$ | Same |
| S | $80\pm10$ | $80\pm10$ | Same |
| M | $95\pm10$ | $95\pm10$ | Same |
| L | $110\pm10$ | $110\pm10$ | same |
| XL | $120\pm10$ | $120\pm10$ | Same |
| Thickness (mm) | |||
| Finger | $\ge0.05$ | $\ge0.05$ | Same |
| Palm | $\ge0.05$ | $\ge0.05$ | Same |
Table 3 Performance comparison
| Item | Proposed device | Predicate (K223903) | device | Result | ||
|---|---|---|---|---|---|---|
| Physical properties | Before aging | Tensile strength | 14MPa, min | 14MPa, min | Same | |
| Ultimate elongation | 500%, min | 500%, min | Same | |||
| After aging | Tensile strength | 14MPa, min | 14MPa, min | Same | ||
| Ultimate elongation | 400%, min | 400%, min | Same | |||
| Comply with ASTM D6319 | Comply with ASTM D6319 | Same | ||||
| Freedom from holes | Be free from holes when tested in | |||||
| accordance with ASTM D5151 | ||||||
| G-1, AQL 2.5 | Be free from holes when tested in accordance with | |||||
| ASTM D5151 | ||||||
| G-1, AQL 2.5 | Same | |||||
| Residual Powder | Meet the requirements of ASTM | |||||
| D6124 | Meet the requirements of | |||||
| ASTM D6124 | Same |
Table 4 Chemotherapy Permeation and Fentanyl Citrate Comparison Claim:
| Tested Chemotherapy Drug and
| Concentration | Minimum breakthrough detection time in minutes | Result | |
|---|---|---|---|
| Proposed device | Predicate device (K223903) | ||
| Carmustine (3.3mg/mL 3,300 ppm) | 11.1 | 14.7 | Similar |
| Cisplatin (1.0 mg/mL 1,000 ppm) | >240 | >240 | Same |
| Cyclophosphamide (20 mg/mL 20,000 ppm) | >240 | >240 | Same |
| Cytarabine (Cytosine) (100 mg/mL 100,000 ppm) | >240 | >240 | Same |
| Dacarbazine (10 mg/mL 10,000 ppm) | >240 | >240 | Same |
| Doxorubicin (Adriamycin) (2.0 mg/mL 2,000 ppm) | >240 | >240 | Same |
| Etoposide (Toposar) (20.0 mg/mL 20,000 ppm) | >240 | >240 | Same |
9
| Fluorouracil (5 Flu) (50.0 mg/mL 50,000 ppm) | >240 | >240 | Same |
|---|---|---|---|
| Ifosfamide (50.0 mg/mL 50,000 ppm) | >240 | >240 | Same |
| Methotrexate (25.0 mg/mL 25,000 ppm) | >240 | >240 | Same |
| Mitomycin C (0.5 mg/mL 500 ppm) | >240 | >240 | Same |
| Mitoxantrone HCL (2.0 mg/mL 2,000 ppm) | >240 | >240 | Same |
| Paclitaxel (6.0 mg/mL 6,000 ppm) | >240 | >240 | Same |
| Thiotepa (10.0 mg/mL 10,000 ppm) | 34.8 | 13.6 | Similar |
| Vincristine Sulfate (1.0 mg/mL 1,000 ppm) | >240 | >240 | Same |
| Fentanyl Citrate Injection (100 mcg/2mL) | >240 | >240 | Same |
Analysis: Minor differences on the penetration time of carmustine and thiotepa between the proposed device and the predicate device, which will not raise any new safety or performance concerns.
| Table 5 Biocompatibility comparison | ||
|---|---|---|
| -- | ------------------------------------- | -- |
| Item | Proposed device | Predicate device (K223903) | Result |
|---|---|---|---|
| Material | Nitrile | Nitrile | Same |
| Biocompatibility | |||
| Irritation | |||
| ISO 10993-23 | Under the conditions of the study, not an irritant. | Comply with ISO 10993-10 | Same |
| Sensitization | |||
| ISO 10993-10 | Under the conditions of the study, not a sensitizer. | ||
| In Vitro Cytotoxicity | |||
| ISO 10993-5 | Under the conditions of the study, the test article extract showed potential toxicity. | Not available | Different |
| Acute Systemic Toxicity | |||
| ISO 10993-11 | Under the conditions of the study, the device extract does not | Not available | Different |
10
| induce | acute | ||
|---|---|---|---|
| systemic | toxicity | ||
| response. |
Analysis: In vitro cytotoxicity and acute systemic toxicity information for the predicate device is not publicly available. This does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment.
G. Summary of Non-Clinical Testing
A Biocompatibility
Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is Limited (≤24h). The following tests for the subject device were conducted to evaluate the biocompatibility:
- ISO 10993-5: In Vitro Cytotoxicity
- ISO 10993-23: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- ISO 10993-11: Acute Systemic Toxicity
△ Performance Testing
Physical performance testing of the proposed device was conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application and are tested for use with chemotherapy drugs and Fentanyl per ASTM D6978 standard.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
| Test Method | Purpose | Acceptance Criteria | Results | ||
|---|---|---|---|---|---|
| Dimensions (width) | |||||
| (thickness) | |||||
| ASTM D6319-19 | The purpose of the test is to | ||||
| evaluate the physical | |||||
| dimension of the glove | Length | ||||
| 220mm min for XS, S | |||||
| 230mm min for M, L, XL | Pass | ||||
| Width | |||||
| XS: 70±10mm | |||||
| S: 80±10mm | |||||
| M: 95±10mm | |||||
| L:110±10mm | |||||
| XL: 120±10mm | Pass | ||||
| Palm - 0.05mm min. | Pass | ||||
| Finger-0.05mm min. | |||||
| Physical properties | |||||
| ASTM D6319-19 | The purpose of the test is to | ||||
| evaluate the tensile strength and | |||||
| ultimate elongation | |||||
| before and after aging | Tensile Strength: | ||||
| Before Aging ≥14 MPa, min. | |||||
| After Aging ≥14 MPa, min. | |||||
| Elongation: | Pass |
11
| | | Before Aging 500%, min.
After Aging 400%, min. | |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|------|
| Freedom from holes
ASTM D5151-19 | The purpose of the test is to
detect holes in the gloves | No leakage at sampling level of G-1,
AQL 2.5 | Pass |
| Residual Powder
ASTM D6124-
06(Reapproved
2017) | The purpose of the test is to
detect the powder residue in
the glove |