(295 days)
Not Found
No
The document describes a physical medical device (examination gloves) and its performance characteristics based on standard testing methods. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, primarily serving as a barrier. While it is a medical device, its function is protective and diagnostic/preventative, not therapeutic.
No
Explanation: The device is described as a "powder-free patient examination glove" intended to "prevent contamination between patient and examiner." Its function is protective, creating a barrier, and it does not gather or interpret data to determine the presence, absence, or nature of a disease or medical condition, which is the primary function of a diagnostic device. The testing performed relates to the glove's barrier properties against chemicals, not its ability to diagnose.
No
The device described is a physical medical device (examination gloves) and does not involve any software component.
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 for protection, not a device used to perform tests on samples taken from the human body to provide diagnostic information.
- Device Description: The description focuses on the physical characteristics and materials of the glove, and its testing against chemical permeation. This aligns with a protective barrier device.
- Performance Studies: The performance studies listed are related to the physical properties of the glove (strength, elongation, freedom from holes, residual powder) and its resistance to chemical permeation (chemotherapy drugs, fentanyl). These are not studies related to diagnostic accuracy or the analysis of biological samples.
- Key Metrics: The key metrics reported are physical measurements and breakthrough times for chemicals, not diagnostic performance metrics like sensitivity, specificity, or AUC.
- Predicate Device: The predicate device is also a patient examination glove, further supporting the classification as a protective barrier device.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This glove does not perform any such tests. Its function is to provide a physical barrier.
N/A
Intended Use / Indications for Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU)(3.3 mg/ml) | 12.1 min. |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 min. |
| Doxorubicin Hydrichloride (2.0mg/) | >240 min. |
| Etoposide (Toposar) (20.0mg/ml) | >240 min. |
| Fluorouracil (50.0mg/ml) | >240 min. |
| Methotrexate (25.0 mg/ml) | >240 min. |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 min. |
| Thiotepa(10.0 mg/ml) | 10.1 min. |
| Vincristine Sulfate(1.0 mg/ml) | >240 min. |
| Cisplatin(1.0 mg/ml) | >240 min. |
| Dacarbazine(10 mg/ml) | >240 min. |
| Mitomycin C(0.5 mg/ml) | >240 min. |
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 12.1 minutes and Thiotepa:10.1 minutes.
Warning: Do not use with Carmustine or Thiotepa
| Fentanyl Citrate & Concentration | Minimum Breakthrough Detection Times |
|---|---|
| Fentanyl Citrate Injection(100 mcg/2ml) | >240 min. |
Product codes
LZA, LZC, OPJ, QDO
Device Description
The Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate. Aka Synguard C+ Nitrile Exam Gloves are non-sterile, single use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. Chlorination is applied to the inner surface of the glove to make donning easy.
Characteristic:
- Ambidextrous with beaded cuff and straight fingers
- Finger-textured,
- Blue colored
- Containing Hyaluronic Acid coating.
- Six (6) sizes extra-small, small, medium, large, extra-large and XXL.
- Tested against chemotherapy drugs and fentanyl citrate.
The gloves are designed to meets the specifications of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
The following non-clinical tests were performed:
- ASTM D6319-19 Standard Specification for Nitrile examination Gloves for Medical Application.
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
- ISO 10993-23 First Edition 2021-01 Biological Evaluation of Medical Devices Part 23, Tests for Irritation.
- ISO 10993-10 Fourth Edition 2021-11 Biological Evaluation of Medical Devices - Part 10, Tests for Skin Sensitization.
- ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices Part 5, Tests for In Vitro Cytotoxicity.
- ISO 10993-11 Third Edition 2017-09 Biological Evaluation of Medical Devices Part 11, Tests for Systemic Toxicity.
The conclusions drawn from the nonclinical tests demonstrate that Anhui Intco Medical Products Co., Ltd. Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate is as safe, as effective, and performs as well as or better than the legally marketed predicate device K200671.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU)(3.3 mg/ml) | 12.1 min. |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 min. |
| Doxorubicin Hydrichloride (2.0mg/) | >240 min. |
| Etoposide (Toposar) (20.0mg/ml) | >240 min. |
| Fluorouracil (50.0mg/ml) | >240 min. |
| Methotrexate (25.0 mg/ml) | >240 min. |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 min. |
| Thiotepa(10.0 mg/ml) | 10.1 min. |
| Vincristine Sulfate(1.0 mg/ml) | >240 min. |
| Cisplatin(1.0 mg/ml) | >240 min. |
| Dacarbazine(10 mg/ml) | >240 min. |
| Mitomycin C(0.5 mg/ml) | >240 min. |
| Fentanyl Citrate & Concentration | Minimum Breakthrough Detection Times |
|---|---|
| Fentanyl Citrate Injection(100 mcg/2ml) | >240 min. |
Predicate Device(s)
Reference Device(s)
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2024
Anhui Intco Medical Products Co., Ltd % Deze Wang Official Correspondent Intco Medical Industries, Inc 805 Barrington Ave Ontario, California 91764
Re: K231365
Trade/Device Name: Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, OPJ, ODO Dated: January 3, 2024 Received: January 18, 2024
Dear Deze 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,
Allan Guan -S
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) K231365
Device Name
Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate, aka Synguard C+ Nitrile Exam Gloves
Indications for Use (Describe)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|
| Carmustine (BCNU)(3.3 mg/ml) | 12.1 min. |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 min. |
| Doxorubicin Hydrichloride (2.0mg/) | >240 min. |
| Etoposide (Toposar) (20.0mg/ml) | >240 min. |
| Fluorouracil (50.0mg/ml) | >240 min. |
| Methotrexate (25.0 mg/ml) | >240 min. |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 min. |
| Thiotepa(10.0 mg/ml) | 10.1 min. |
| Vincristine Sulfate(1.0 mg/ml) | >240 min. |
| Cisplatin(1.0 mg/ml) | >240 min. |
| Dacarbazine(10 mg/ml) | >240 min. |
| Mitomycin C(0.5 mg/ml) | >240 min. |
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 12.1 minutes and Thiotepa:10.1 minutes.
Warning: Do not use with Carmustine or Thiotepa
| Fentanyl Citrate & Concentration | Minimum Breakthrough Detection Times |
|---|---|
| Fentanyl Citrate Injection(100 mcg/2ml) | >240 min. |
Type of Use (Select one or both, as applicable)
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
Anhui Intco Medical Products Co., Ltd.
No.6 Haitang South Road, Suixi, Anhui, China
510(K) SUMMARY K231365
(As requirement by 21 CFR 807.92)
1. Submitter's Identification:
Anhui Intco Medical Products Co, Itd. No.6 Haitang South Road, Suixi Wuhu Modern Industrial Park Suixi County, Huaibei City, Anhui Province,China
Contact Person :
Max Li Tel: 86-18918364816
Date summary prepared: March 1, 2024
2. Product Trade Name:
Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate.
Aka Synguard C+ Nitrile Exam Gloves
Device Classification Name: 3.
Patient Examination gloves (21 CFR 880.6250)
4. Device Class:
Class I.
న్. Product Code:
LZA, LZC,OPJ,QDO.
Predicate Devices: 6.
K200671 - Ansell Healthcare Products LLC Powder-Free Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl
7. Reason for 510(k) Submission:
New device.
8. Device Description:
The Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate. Aka Synguard C+ Nitrile Exam Gloves are non-sterile, single
6
use only, disposable, powder free examination gloves. The glove is made of nitrile butadiene rubber. Chlorination is applied to the inner surface of the glove to make donning easy. Characteristic:
- · Ambidextrous with beaded cuff and straight fingers
- Finger-textured,
- Blue colored
P
- · Containing Hyaluronic Acid coating.
- · Six (6) sizes extra-small, small, medium, large, extra-large and XXL.
- · Tested against chemotherapy drugs and fentanyl citrate.
The gloves are designed to meets the specifications of ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
9. Indications for Use:
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Test Chemotherapy drug & Concentration
Average Breakthrough Detection Time (Minutes)
| Carmustine (BCNU)(3.3 mg/ml) | 12.1 min. |
|---|---|
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 min. |
| Doxorubicin Hydrichloride (2.0mg/) | >240 min. |
| Etoposide (Toposar) (20.0mg/ml) | >240 min. |
| Fluorouracil (50.0mg/ml) | >240 min. |
| Methotrexate (25.0 mg/ml) | >240 min. |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 min. |
| Thiotepa(10.0 mg/ml) | 10.1 min. |
| Vincristine Sulfate(1.0 mg/ml) | >240 min. |
| Cisplatin(1.0 mg/ml) | >240 min. |
| Dacarbazine(10 mg/ml) | >240 min. |
| Mitomycin C(0.5 mg/ml) | >240 min. |
Warning: Do not use with Carmustine or Thiotepa
Fentanyl Citrate & Concentration Minimum Breakthrough Detection Times Fentanyl Citrate Injection(100 mcg/2ml)
>240 min.
10. Technological Characteristics Comparison Table:
| Characteristics | Acceptance Criteria | Anhui Intco Medical
Products Co., Ltd.
Nitrile Patient Examination
Gloves with Hyaluronic
Acid Blue Colored and
Tested for Use with
Chemotherapy Drugs and
Fentanyl citrate | Ansell Healthcare Products
LLC Powder-Free Microflex®
Nitrile Patient Examination
Gloves with Aloe and
Chamomile Pink Colored
Tested for Use with
Chemotherapy Drugs and
Fentanyl | Comparison
Conclusions |
| ----------------- | --------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------- |
|---|
7
| K-Number | K231365 | K200671 | ||
|---|---|---|---|---|
| Product Code | LZA,LZC,OPJ,QDO | LZA,LZC,OPJ,QDO | LZA, LZC,QDO | |
| Intended use | / | A powder-free patient | ||
| examination glove is a | ||||
| disposable device intended | ||||
| for medical purposes that | ||||
| is worn on the examiner's | ||||
| hand to prevent | ||||
| contamination between | ||||
| patient and examiner. The | ||||
| glove was tested for use | ||||
| with Chemotherapy Drugs | ||||
| and Fentanyl Citrate as per | ||||
| ASTM D6978-05 | ||||
| Standard Practice for | ||||
| Assessment of Medical | ||||
| Gloves to Permeation by | ||||
| Chemotherapy Drugs. | A powder-free patient | |||
| examination glove is a | ||||
| disposable device intended for | ||||
| medical purposes that is worn | ||||
| on the examiner's hand to | ||||
| prevent contamination between | ||||
| patient and examiner. The | ||||
| glove was tested for use with | ||||
| Chemotherapy Drugs as per | ||||
| ASTM D6978-05 Standard | ||||
| Practice for Assessment of | ||||
| Medical Gloves to Permeation | ||||
| by Chemotherapy Drugs. | Same | |||
| Material used | Nitrile | Nitrile | Nitrile | Identical |
| Color | Blue | Blue | Blue | Same |
| Single use | Single Use | Yes | Yes | Same |
| Non Sterile | Non Sterile | Non Sterile | Non Sterile | Same |
| Other | / | Hyaluronic Acid | ||
| coated on | Aloe and Chamomile | |||
| coated on | Different(1) | |||
| the donning surface | the donning surface | |||
| Dimensions | Overall Length (mm) | |||
| For XS, S,Min 220mm | ||||
| For M,L,XL,XXL | ||||
| Min 230mm | ||||
| Width (± 10mm) | ||||
| Size XS = 70mm | ||||
| Size S = 80mm | ||||
| Size M = 95mm | ||||
| Size L = 110mm | ||||
| Size XL = 120mm | ||||
| Size XXL = 130mm | ||||
| Thickness at Palm (mm) | ||||
| Min; 0.05mm | ||||
| Thickness at Finger Tip | ||||
| (mm) Min 0.05 mm | Complies with ASTM | |||
| D6319-19 | ||||
| X Small 70±10 | ||||
| Small 80 ±10 | ||||
| Medium 95±10 | ||||
| Large 110 ±10 | ||||
| X large 120 ±10 | ||||
| XX Large 130 ±10 | ||||
| Thickness | ||||
| Palm - 0.05mm min. | ||||
| Finger - 0.05 mm min. | Complies with ASTM | |||
| D6319-10 | ||||
| X Small 75±5 | ||||
| Small 85 ±5 | ||||
| Medium 95±5 | ||||
| Large 105 ±5 | ||||
| X large 115 ±5 | ||||
| XX Large N/A | ||||
| Thickness | ||||
| Palm - 0.06mm min. | ||||
| Finger - 0.09 mm min | Similar | |||
| Physical | ||||
| properties | Before Ageing | |||
| Tensile Strength (MPa) = | ||||
| 14min | ||||
| Ultimate Elongation (%) = | ||||
| 500min | ||||
| After Aging | ||||
| Tensile Strength (MPa) = | ||||
| 14min | ||||
| Ultimate Elongation (%) = | ||||
| 400min | Meets ASTM D6319- | |||
| 19 | ||||
| Tensile Strength: | ||||
| Before Aging 14 MPa, | ||||
| min. | ||||
| After Aging 14 MPa, | ||||
| min. | ||||
| Elongation: | ||||
| Before Aging 500% min. | ||||
| After Aging 400% | ||||
| min. | Meets ASTM D6319-10 | |||
| Tensile Strength: | ||||
| Before Aging 16 MPa, | ||||
| min. | ||||
| After Aging 14 MPa, | ||||
| min. | ||||
| Elongation: | ||||
| Before Aging 500% min. | ||||
| After Aging 400% min. | Meets the | |||
| criteria | ||||
| Freedom from | ||||
| pinholes | AQL 2.5 | |||
| Inspection Level G-1 | In accordance with ASTM | |||
| D6319-19 and | ||||
| ASTM D5151-19, G-1, | ||||
| AQL 2.5 | In accordance with ASTM | |||
| D6319-10 and | ||||
| ASTM D5151-06 , AQL 2.5 | Meets the | |||
| criteria | ||||
| Residual | ||||
| Powder | Less than 2mg per glove | |||
| ASTM D 6124-06 | Average powder residue | |||
| 240 min. |
-
Doxorubicin
Hydrochloride (2.0mg/),
Breakthrough time: >240 min. -
Etoposide (Toposar)
(20.0mg/ml), Breakthrough
time: >240 min. -
Fluorouracil
(50.0mg/ml), Breakthrough
time:>240 min. -
Methotrexate
(25.0 mg/ml), Breakthrough
time: >240 min. -
Paclitaxel (Taxol)
(6.0 mg/ml), Breakthrough
time: >240 min. -
Thiotepa
Breakthrough time:
10.1 min. -
Vincristine Sulfate
(1.0 mg/ml), Breakthrough
time:>240 min. -
Cisplatin
(1.0 mg/ml), Breakthrough
time:>240 min. -
Dacarbazine
(10 mg/ml), Breakthrough
time:>240 min. -
Mitomycin C
(0.5 mg/ml), Breakthrough
time:>240 min. -
Fentanyl Citrate
Injection
(100 mcg/2ml),
Breakthrough time:>240
min. | 2) Cyclophosphamide
(Cytoxan), (20.0 mg/ml),
Breakthrough time:
240 min.
-
Doxorubicin Hydrochloride
(2.0mg/), Breakthrough
time: >240 min. -
Etoposide (Toposar)
(20.0mg/ml), Breakthrough
time: >240 min. -
Fluorouracil (50.0mg/ml),
Breakthrough time:>240 min. -
Methotrexate
(25.0 mg/ml), Breakthrough
time: >240 min. -
Paclitaxel (Taxol)
(6.0 mg/ml), Breakthrough
time: >240 min. -
Thiotepa
Breakthrough time:
67.1 min.
9)Vincristine Sulfate
(1.0 mg/ml), Breakthrough
time:>240 min. |
10
Analysis (1): The proposed device added the Hyaluronic Acid. while the predicate device added the Aloe and Chamomile, they are not the animal derived. Biocompatibility testing is the safety and performance testing has been done to the proposed device and the results showed that the device meets the requirements of standard ASTM D6319-19. Therefore, this difference does not raise any new safety or performance questions.
11. Non-clinical Testing
The following non-clinical tests were performed:
- ASTM D6319-19 Standard Specification for Nitrile examination Gloves for Medical Application. ●
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical ● Gloves.
- ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
- ISO 10993-23 First Edition 2021-01 Biological Evaluation of Medical Devices Part 23, Tests for ● Irritation.
- ISO 10993-10 Fourth Edition 2021-11 Biological Evaluation of Medical Devices - Part 10, Tests for Skin Sensitization.
- ISO 10993-5 Third Edition 2009-06-01 Biological Evaluation of Medical Devices Part 5, Tests for ● In Vitro Cytotoxicity.
- ISO 10993-11 Third Edition 2017-09 Biological Evaluation of Medical Devices Part 11, Tests for ● Systemic Toxicity.
12. Clinical Testing
N/A.
13. Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that Anhui Intco Medical Products Co., Ltd. Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl citrate is as safe, as effective, and performs as well as or better than the legally marketed predicate device K200671. Ansell Healthcare Products LLC Powder-Free Microflex® Nitrile Patient Examination Gloves with Aloe and Chamomile Pink Colored Tested for Use with Chemotherapy Drugs and Fentanyl.