(168 days)
Not Found
No
The device is a physical examination glove and the summary describes standard material and performance testing, with no mention of AI or ML.
No
The device is a glove intended to prevent contamination between patient and examiner, primarily for protection rather than treating a medical condition.
No
Explanation: The device is a nitrile examination glove intended to prevent contamination, not to diagnose medical conditions or provide diagnostic information.
No
The device described is a physical product (nitrile 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 clearly states the gloves are "to be worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the physical characteristics and materials of the gloves, not on any components or processes used for in vitro diagnostic testing.
- Performance Studies: The performance studies listed are related to the physical properties, safety, and barrier function of the gloves (e.g., water leak test, cytotoxicity, chemotherapy drug permeation). There are no studies related to analyzing samples from the human body for diagnostic purposes.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such function.
The testing for chemotherapy drug permeation is a safety feature related to the intended use as a barrier, not a diagnostic test.
N/A
Intended Use / Indications for Use
The nitrile examination glove is intended to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carboplatin, 10 mg/ml >240 min. Carmustine (BCNU), 3.3 mg/ml 27.5 min Cisplatin, 1.0 mg/ml >240 min Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min Doxorubicin HCI, 2.0 mg/ml >240 min Etoposide, 20.0 mg/ml >240 min Fluorouracil, 50.0 mg/ml >240 min Paclitaxel, 6.0 mg/ml >240 min Thio Tepa, 10.0 mg/ml 88.2 min
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 27.5 Minutes, Thio Tepa 10.0 mg/ml 88.2 Minutes.
Warning: Please do not use with Carmustine and Thio Tepa.
Over-The-Counter Use (21 CFR 801 Subpart C)
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ
Device Description
The proposed device (Mode: NG101) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, include XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge. This is a single-use, powder-free, non-sterile device.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 in accordance with following standards to verify that the proposed device met all design specifications.
- . ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-19, Test Method for Detection of Holes in Medical Gloves .
- ASTM D6124-06(2017), Test Method for Residual Powder on Medical Gloves .
- ASTM D573-04(2019), Test Method for Rubber-Deterioration in an Air Oven ●
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For . In Vitro Cytotoxicity
- ISO 10993-10: 2010, Biological Evaluation Of Medical Devices Part 10: Tests . For Irritation And Skin Sensitization.
- ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical . Gloves to Permeation by Chemotherapy Drugs
| Test
| Methodology | Tested sample | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| ASTM | ||||
| D6319-19 | Final finished | |||
| product | Physical | |||
| Dimension | The actual | |||
| measured | ||||
| dimension of the | ||||
| gloves shall be | ||||
| meet the stated | ||||
| tolerance | ||||
| specified in Table | ||||
| 2 of the ASTM D | ||||
| 6319-19 | Meet the | |||
| requirement | ||||
| ASTM | ||||
| D6319-19 | Final finished | |||
| product | Determination of | |||
| Physical | ||||
| Properties | Before and after | |||
| accelerated aging, | ||||
| the gloves shall | ||||
| conform to the | ||||
| physical | ||||
| requirements in | ||||
| the Table 3 of | ||||
| ASTM 6319-19) | Meet the | |||
| requirement | ||||
| ASTM | ||||
| D5151-19 | Final finished | |||
| product | Water Leak Test | |||
| for Detection of | ||||
| Holes | The gloves shall | |||
| be free from hole | ||||
| when tested in | ||||
| accordance with | ||||
| the method given | ||||
| in ASTM D5151 - | ||||
| 19 | ||||
| AQL =2.5 | Meet the | |||
| requirement | ||||
| ASTM | ||||
| D6124- | ||||
| 06(2017) | Final finished | |||
| product | Residual Powder | |||
| Content Test | The powder | |||
| residue content | ||||
| shall be not more | ||||
| than 2mg per | ||||
| gloves. | Meet the | |||
| requirement | ||||
| ISO 10993- | ||||
| 5: 2009 | Final finished | |||
| product | In Vitro | |||
| Cytotoxicity | The MEM test | |||
| extract shows no | ||||
| cytotoxic potential | ||||
| to L929 mouse | ||||
| fibroblast cells. | Meet the | |||
| requirement | ||||
| ISO 10993- | ||||
| 10: 2010 | Final finished | |||
| product | Skin Sensitization | The test article | ||
| extracts show no | ||||
| evidence of | ||||
| causing delayed | ||||
| dermal contact | ||||
| sensitization in the | ||||
| guinea pig. | Meet the | |||
| requirement | ||||
| ISO 10993- | ||||
| 10: 2010 | Final finished | |||
| product | Skin irritation | There is no | ||
| erythema and no | ||||
| edema observed | ||||
| on the skin of the | ||||
| animals treated | ||||
| with the test | ||||
| extracts | Meet the | |||
| requirement | ||||
| ASTM D6978-05 | Final finished product | Chemotherapy Drugs | Carboplatin, 10 mg/ml >240 min. | |
| Carmustine (BCNU), 3.3 mg/ml 27.5 min | ||||
| Cisplatin, 1.0 mg/ml >240 min | ||||
| Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min | ||||
| Doxorubicin HCl, 2.0 mg/ml >240 min | ||||
| Etoposide, 20.0 mg/ml >240 min | ||||
| Fluorouracil, 50.0 mg/ml >240 min | ||||
| Paclitaxel, 6.0 mg/ml >240 min | ||||
| Thio Tepa, 10.0 mg/ml | ||||
| 88.2 min | Except for Carmustine and Thio Tepa, acceptance criteria were met. |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image 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 and the words "U.S. FOOD & DRUG ADMINISTRATION".
December 1, 2022
Fitone Latex Products Co., Ltd. Guangdong % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza 555 West Guangzhong Road Shanghai, 200072 China
Re: K221747
Trade/Device Name: Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: November 2, 2022 Received: November 2, 2022
Dear Stuart Situ:
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).
Sincerelv.
Bifeng Qian -S
Bifeng Oian, 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221747
Device Name
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs
Indications for Use (Describe)
The nitrile examination glove is intended to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019)Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Carboplatin, 10 mg/ml >240 min. Carmustine (BCNU), 3.3 mg/ml 27.5 min Cisplatin, 1.0 mg/ml >240 min Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min Doxorubicin HCI, 2.0 mg/ml >240 min Etoposide, 20.0 mg/ml >240 min Fluorouracil, 50.0 mg/ml >240 min Paclitaxel, 6.0 mg/ml >240 min Thio Tepa, 10.0 mg/ml 88.2 min
Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 27.5 Minutes, Thio Tepa 10.0 mg/ml 88.2 Minutes.
Warning: Please do not use with Carmustine and Thio Tepa.
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 K221747
I. Submitter
Fitone Latex Products Co., Ltd. Guangdong No.5 Huitong road, Lingbei Industrial Zone, Suixi, 524338 Zhanjiang, Guangdong, China
Contact person: Christine Ou Position: Manager Tel.: 0759-7905808 E-mail: market-intl@fitonelatex.com
Preparation date: Dec.1 2022
Submission Correspondent
Ms. Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: stuart.situ@landlink-healthcare.com
US Agent
Qihui Zhang ZYPPEL LLC 1337 Massachusetts Avenue #158 Arlington MA, MA US 02476
II. Proposed Device
| Device Trade Name: | Nitrile Patient Examination Gloves Tested For Use
With Chemotherapy Drugs |
|--------------------|------------------------------------------------------------------------------|
| Model: | NG101 |
| Common name: | Patient Examination Glove (Tested For Use With
Chemotherapy Drugs) |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LZA, LZC, OPJ |
| Review Panel: | General Hospital |
4
III. Predicate Devices
| 510(k) Number: | K211220 |
|---|---|
| Trade name: | Nitrile Patient Examination Gloves Blue Tested For Use |
| With Chemotherapy Drugs | |
| Common name: | Patient Examination Glove (Tested For Use With |
| Chemotherapy Drugs) | |
| Classification: | Class I |
| Product Code: | LZA, LZC, OPJ |
| Manufacturer | GUANGDONG KINGFA SCI.&TECH.CO.,LTD. |
IV. Device description
The proposed device (Mode: NG101) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, include XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge. This is a single-use, powder-free, non-sterile device.
The gloves are designed and manufactured in accordance with the ASTM D6319-10 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019)
V. Indication for use
The nitrile examination glove is intended to be worn on the examiner's hand to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
These gloves were tested for use with chemotherapy drugs per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Tested chemotherapy drugs are as follows:
Carboplatin, 10 mg/ml >240 min.
Carmustine (BCNU), 3.3 mg/ml 27.5 min
Cisplatin, 1.0 mg/ml >240 min
Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min
5
Doxorubicin HCI, 2.0 mg/ml >240 min Etoposide, 20.0 mg/ml >240 min Fluorouracil, 50.0 mg/ml >240 min Paclitaxel, 6.0 mg/ml >240 min Thio Tepa, 10.0 mg/ml 88.2 min
- · Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 27.5 Minutes; Thio Tepa 10.0 mg/ml 88.2 Minutes.
- · Warning: Please do not use with Carmustine and Thio Tepa.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device
(K221747) | Predicate device
(K211220) | Discussion |
|--------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------------|
| Product name | Nitrile Patient
Examination Gloves
Tested For Use With
Chemotherapy Drugs | Nitrile Patient
Examination Gloves
Blue Tested For Use
With Chemotherapy
Drugs | - |
| Product Code | LZA, LZC, OPJ | LZA, LZC, OPJ | Same |
| Regulation
No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classificatio
n | Class I | Class I | Same |
| Powder free | Yes | Yes | Same |
Table 1 Comparison of Nitrile Patient Examination Gloves
6
| Indication
| for use | Similar¹ | ||
|---|---|---|---|
| The nitrile 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. | |||
| These gloves were | |||
| tested for use with | |||
| Chemotherapy drugs as | |||
| per ASTM D6978-05 | |||
| (Reapproved 2019) | |||
| Standard Practice for | |||
| Assessment of Medical | |||
| Gloves of Permeation by | |||
| Chemotherapy Drugs | A 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. | |||
| These gloves were | |||
| tested for use with | |||
| Chemotherapy drugs | |||
| as per ASTM D6978-05 | |||
| (Reapproved 2019) Standard Practice | |||
| for Assessment of Medical Gloves of | |||
| Permeation by | |||
| Chemotherapy Drugs | |||
| Main | Powder-Free Nitrile | Powder-Free Nitrile | Same |
| Material | |||
| Color | Blue | Blue | Same |
| Size | X-small, Small, Medium, | ||
| Large, X large | small, medium, large, x- | ||
| large | Similar² | ||
| Dimensions | |||
| – | |||
| Length | Complies with ASTM | ||
| D6319-19 | |||
| XS (220mm min) | |||
| S (220mm min) | |||
| M (230mm min) | |||
| L (230mm min) | |||
| XL (230mm min) | Complies with ASTM | ||
| D6319-19 | |||
| S (220mm min) | |||
| M (230mm min) | |||
| L (230mm min) | |||
| XL (230mm min) | Similar² | ||
| Dimensions | |||
| – | |||
| Width | Complies with ASTM | ||
| D6319-19 | |||
| XS (70±10mm) | |||
| S (80±10mm) | |||
| M (95±10mm) | |||
| L (110±10mm) | |||
| XL (120±10mm) | Complies with ASTM | ||
| D6319-19 | |||
| Small (80±10mm) | |||
| Medium (95±10mm) | |||
| Large (110±10mm) | |||
| X large (120±10mm) | Similar² | ||
| Dimensions | |||
| – | |||
| Thickness | Complies with: | ||
| ASTM D6319-19 | |||
| Palm: 0.05mm min | |||
| Finger: 0.08mm min | Complies with: | ||
| ASTM D6319-19 | |||
| Palm: 0.05mm min | |||
| Finger: 0.11mm min | Similar² | ||
| Physical | |||
| Properties | Complies with: | ||
| ASTM D6319-19 | |||
| minimum: | |||
| Tensile Strength: | |||
| Before Aging ≥ 14 MPa, | |||
| min. | |||
| After Aging ≥ 14 MPa, | |||
| min. | |||
| Elongation: | |||
| Before Aging 500%, min. | |||
| After Aging 400%, min. | Complies with: | ||
| ASTM D6319-19 | |||
| minimum: | |||
| Tensile Strength: | |||
| Before Aging ≥14 MPa, | |||
| min. | |||
| After Aging ≥ 14 MPa, | |||
| min. | |||
| Elongation: | |||
| Before Aging 500%, | |||
| min. | |||
| After Aging 400%, min. | Same | ||
| Freedom | |||
| from | |||
| Holes | The gloves shall be free | ||
| from hole when tested in | |||
| accordance with the | |||
| method given in ASTM | |||
| D5151 | The gloves shall be free | ||
| from hole when tested in | |||
| accordance with the | |||
| method given in ASTM | |||
| D5151 | Same | ||
| Powder or | |||
| Powder- | |||
| Free | Powder-Free | Powder-Free | Same |
| Residual | |||
| Powder | Complies with: | ||
| ASTM D6319-19 | |||
| 240 min. | |||
| Carmustine (BCNU), 3.3 | |||
| mg/ml 27.5 min | |||
| Cisplatin, 1.0 mg/ml >240 | |||
| min | |||
| Cyclophosphamide | |||
| (Cytoxan), 20.0 | |||
| mg/ml >240 min | |||
| Doxorubicin HCl, 2.0 | |||
| mg/ml >240 min | |||
| Etoposide, 20.0 | |||
| mg/ml >240 min | |||
| Fluorouracil, 50.0 | |||
| mg/ml >240 min | |||
| Paclitaxel, 6.0 | |||
| mg/ml >240 min | |||
| Thio Tepa, 10.0 mg/ml | |||
| 88.2 min | Carmustine (BCNU) 3.3 | ||
| mg/ml 65.3 minutes | |||
| Cisplatin 1.0 | |||
| mg/ml >240 minutes | |||
| Cyclophosphamide | |||
| (Cytoxan) 20.0 | |||
| mg/ml >240 minutes | |||
| Dacarbazine (DTIC)10.0 | |||
| mg/ml >240 minutes | |||
| Doxorubicin | |||
| Hydrochloride 2.0 | |||
| mg/ml >240 minutes | |||
| Etoposide (Toposar) | |||
| 20.0 mg/ml >240 | |||
| minutes | |||
| Fluorouracil 50.0 | |||
| mg/ml >240 minutes | |||
| Paclitaxel (Taxol) 6.0 | |||
| mg/ml >240 minutes | |||
| Thiotepa 10.0 mg/ml | |||
| 58.3minutes | Similar |
7
8
1Except the device name, the contents of indications for use are identical.
²As above comparison, the difference in the dimensions between the subject and predicate devices does not raise additional questions for safety and effectiveness of the device.
9
3The surface of the fingertips of the proposed device and predicate device is different. Fingers of the proposed device are textured. However, the thickness or other performance of the proposed device complies with ASTM D6319-19. Therefore, the difference does not raise additional questions for safety and effectiveness of the device.
4The Cytotoxicity test result of proposed device and predicate device is different. The test result of proposed device showed no cytotoxic potential to L929 mouse fibroblast cells. Acute systemic toxicity test is not necessary for the proposed device.
VII. Non-Clinical Testing
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- . ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-19, Test Method for Detection of Holes in Medical Gloves .
- ASTM D6124-06(2017), Test Method for Residual Powder on Medical Gloves .
- ASTM D573-04(2019), Test Method for Rubber-Deterioration in an Air Oven ●
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For . In Vitro Cytotoxicity
- ISO 10993-10: 2010, Biological Evaluation Of Medical Devices Part 10: Tests . For Irritation And Skin Sensitization.
- ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical . Gloves to Permeation by Chemotherapy Drugs
| Test
| Methodology | Tested sample | Purpose | Acceptance Criteria | Results |
|---|---|---|---|---|
| ASTM | ||||
| D6319-19 | Final finished | |||
| product | Physical | |||
| Dimension | The actual | |||
| measured | ||||
| dimension of the | ||||
| gloves shall be | ||||
| meet the stated | ||||
| tolerance | ||||
| specified in Table | Meet the | |||
| requirement | ||||
| 2 of the ASTM D | ||||
| 6319-19 | ||||
| ASTM | ||||
| D6319-19 | Final finished | |||
| product | Determination of | |||
| Physical | ||||
| Properties | Before and after | |||
| accelerated aging, | ||||
| the gloves shall | ||||
| conform to the | ||||
| physical | ||||
| requirements in | ||||
| the Table 3 of | ||||
| ASTM 6319-19) | Meet the | |||
| requirement | ||||
| ASTM | ||||
| D5151-19 | Final finished | |||
| product | Water Leak Test | |||
| for Detection of | ||||
| Holes | The gloves shall | |||
| be free from hole | ||||
| when tested in | ||||
| accordance with | ||||
| the method given | ||||
| in ASTM D5151 - | ||||
| 19 | ||||
| $AQL =2.5$ | Meet the | |||
| requirement | ||||
| ASTM | ||||
| D6124- | ||||
| 06(2017) | Final finished | |||
| product | Residual Powder | |||
| Content Test | The powder | |||
| residue content | ||||
| shall be not more | ||||
| than 2mg per | ||||
| gloves. | Meet the | |||
| requirement | ||||
| ISO 10993- | ||||
| 5: 2009 | Final finished | |||
| product | In Vitro | |||
| Cytotoxicity | The MEM test | |||
| extract shows no | ||||
| cytotoxic potential | ||||
| to L929 mouse | ||||
| fibroblast cells. | Meet the | |||
| requirement | ||||
| ISO 10993- | ||||
| 10: 2010 | Final finished | |||
| product | Skin Sensitization | The test article | ||
| extracts show no | ||||
| evidence of | ||||
| causing delayed | ||||
| dermal contact | ||||
| sensitization in the | ||||
| guinea pig. | Meet the | |||
| requirement | ||||
| ISO 10993- | ||||
| 10: 2010 | Final finished | |||
| product | Skin irritation | There is no | ||
| erythema and no | ||||
| edema observed | ||||
| on the skin of the | ||||
| animals treated | ||||
| with the test | ||||
| extracts | Meet the | |||
| requirement | ||||
| ASTM D6978-05 | Final finished product | Chemotherapy Drugs | Carboplatin, 10 mg/ml >240 min. | |
| Carmustine (BCNU), 3.3 mg/ml 27.5 min | ||||
| Cisplatin, 1.0 mg/ml >240 min | ||||
| Cyclophosphamide (Cytoxan), 20.0 mg/ml >240 min | ||||
| Doxorubicin HCl, 2.0 mg/ml >240 min | ||||
| Etoposide, 20.0 mg/ml >240 min | ||||
| Fluorouracil, 50.0 mg/ml >240 min | ||||
| Paclitaxel, 6.0 mg/ml >240 min | ||||
| Thio Tepa, 10.0 mg/ml | ||||
| 88.2 min | Except for Carmustine and Thio Tepa, acceptance criteria were met. |
10
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VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(K) submission, the Nitrile Patient Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K211220.