(24 days)
Not Found
No
The device is a physical barrier (examination gloves) and the description focuses on material properties and barrier performance, with no mention of AI/ML technology.
No.
The device is described as examination gloves intended to prevent contamination, not to treat, mitigate, or cure a disease or condition.
No
These are examination gloves intended to prevent contamination, not to detect or diagnose a medical condition.
No
The device is a physical product (nitrile examination gloves) and the description focuses on material properties, physical dimensions, and barrier performance, 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 clearly stated as a "non-sterile disposable device intended for medical purposes that is worn on the exammer's hands or finger to prevent contamination between patient and examiner." This describes a barrier device for protection, not a device used to diagnose a condition based on in vitro examination of specimens.
- Device Description: The description focuses on the physical properties and barrier performance of the gloves, including compliance with standards for examination gloves and chemotherapy drug permeation. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies described are related to the physical integrity, barrier properties, and biocompatibility of the gloves. They do not involve diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are typical for IVDs.
- Classification: The device is classified as Class I with product codes LZA, LZC, OPJ (21CFR880.6250), which are classifications for medical gloves, not IVDs.
In vitro diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not perform such a function.
N/A
Intended Use / Indications for Use
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a non-sterile disposable device intended for medical purposes that is worn on the exammer's hands or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes, and can be used with the device.
Cyclophosphamide (20.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Paclitaxel (6.0 mg/ml) Cisplatin (1.0 mg/ml) Dacarbazine (10.0 mg/ml)
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 15 minutes ThioTEPA (10.0 mg/ml): 97 minutes
Warning: Not for Use with: Carmustine, ThioTEPA
Product codes
LZA, LZC, OPJ
Device Description
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per D6978-05(2023). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only. NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) are offered in different sizes: S/M/L/XL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
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
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: 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 D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application; ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs; 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; ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
Key results:
- Physical Dimensions Test (ASTM D6319):
- Length: S: >= 220mm; M/L/XL: >= 230mm. All sizes passed.
- Width: S: 80 +/- 10 mm; M: 95 +/- 10 mm; L: 110 +/- 10 mm; XL: 120 +/- 10 mm. All sizes passed within specifications (e.g., S: 84-86/Pass).
- Thickness: Palm: >= 0.05 mm; Finger: >= 0.05 mm. Passed (Finger: 0.09-0.11/Pass, Palm: 0.07-0.08/Pass).
- Watertightness Test for Detection of Holes (ASTM D5151, ASTM D6319): Met requirements of ASTM D5151 AQL 2.5 (0/125/Pass).
- Powder Content (ASTM D6124, ASTM D6319): Met the requirement of ASTM D 6124 = 14 Mpa; after aging >= 14 Mpa. Passed (before aging: 20-24Mpa, after aging: 15-23Mpa).
- Ultimate Elongation: before aging >= 500 %; after aging >= 400 %. Passed (before aging: 501-598%, after aging: 471-561%).
- Chemotherapy drug claim (ASTM D6978):
- No breakthrough detected up to 240 minutes for Cyclophosphamide (20.0 mg/ml), Doxorubicin HCl (2.0 mg/ml), Etoposide (20.0 mg/ml), Fluorouracil (50.0 mg/ml), Paclitaxel (6.0 mg/ml), Cisplatin (1.0 mg/ml), Dacarbazine (10.0 mg/ml).
- Low permeation times: Carmustine (3.3 mg/ml): 15 minutes; ThioTEPA (10.0 mg/ml): 97 minutes. Warning: Not for Use with: Carmustine, ThioTEPA.
- Cytotoxicity (ISO 10993-5): Under conditions of the study, device extract is cytotoxic.
- Irritation (ISO 10993-10): Under the conditions of the study, not an irritant. / Pass.
- Sensitization (ISO 10993-10): Under the conditions of the study, not a sensitizer. / Pass.
- Acute Systemic Toxicity (ISO 10993-11): Under the conditions of the study, did not show acute systemic toxicity in vivo. / Pass.
Key Metrics
Not Found
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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 12, 2024
Nb Medical Company Limited % Wendy Huang Technical Manager Wenzhou ThiWe Business Consulting Co., Ltd. Room 1203, Building C, Hua'ou Jiayuan, No.50 Tangjiaqiao South Road, Longwan District Wenzhou, Zhejiang 325000 China
Re: K242812
Trade/Device Name: NITRILE 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: August 12, 2024 Received: September 18, 2024
Dear Wendy Huang:
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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bifeng Qian -S
Bifeng Qian, M.D, Ph.D. Assistant Director DHT4C: Division of Infection Control 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) K242812
Device Name NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
Indications for Use (Describe)
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a non-sterile disposable device intended for medical purposes that is worn on the exammer's hands or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes, and can be used with the device.
Cyclophosphamide (20.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Paclitaxel (6.0 mg/ml) Cisplatin (1.0 mg/ml) Dacarbazine (10.0 mg/ml)
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 15 minutes ThioTEPA (10.0 mg/ml): 97 minutes
Warning: Not for 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
K242812
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter Information
| · Company Name: | NB MEDICAL COMPANY LIMITED |
|---|---|
| · Address: | Tay An Industrial Cluster, Tien Hai Town, Tien Hai District, |
| Thai Binh Province, Vietnam | |
| · Phone Number: | +84-934-388877 |
| · Contact: | VU THI VINH |
2.0 Designated Submission Correspondent
| · Company Name: | Wenzhou ThiWe Business Consulting Co., Ltd. | |
|---|---|---|
| · Address: | Room 1203, Building C, Hua'ou Jiayuan, No.50 Tangjiaqiao | |
| South Road, Longwan District, Wenzhou, Zhejiang, 325000, | ||
| CHINA | ||
| · Phone Number: | 86-577-88201260 | |
| · Contact: | Ms. Wendy Huang | |
| · Email: | thiwe_reg@outlook.com |
3.0 Date of Preparation: October 3, 2024
4.0 Device Information
・Trade/Device Name: NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs)
・Model(s): S, M, L, XL (Blue)
・ Common Name: Patient Examination Gloves (Tested For Use With Chemotherapy Drugs)
・510(k) Number: K242812
5
5.0 Classification
- · Device: Polymer Patient Examination Glove & Medical Glove, Specialty & Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs
- · Regulation Description: Non-powdered patient examination glove.
- · Review Panel: General Hospital
- · Product Code: LZA, LZC, OPJ
- · Submission Type: 510(k)
- · Regulation Number: 21 CFR 880.6250
- · Device Class: 1
6.0 Predicate Device Information
- · Device Name: NITRILE EXAMINATION GLOVES
- ・510(k) Number: K220343
- · Manufacturer: NB Medical Co., LTD (i.e. NB MEDICAL COMPANY LIMITED)
7.0 Device Description
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per D6978-05(2023). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, ambidextrous and single use only. NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) are offered in different sizes: S/M/L/XL.
6
8.0 Indications for Use
NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes, and can be used with the device.
Cyclophosphamide (20.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Etoposide (20.0 mg/ml) Fluorouracil (50.0 mg/ml) Paclitaxel (6.0 mg/ml) Cisplatin (1.0 mg/ml) Dacarbazine (10.0 mg/ml)
The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml): 15 minutes ThioTEPA (10.0 mg/ml): 97 minutes
Warning: Not for Use with: Carmustine, ThioTEPA
9.0 Comparison of Intended Use and Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristics of the subject and predicate device.
Table 1: Comparison Table for Subject and Predicate Device
7
| Item | Subject Device
(K242812) | Predicate Device
(K220343) | Comparison |
|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| General Comparison | | | |
| Product Code | LZA, LZC, OPJ | LZA | Different
Analysis 1 |
| Regulation No. | 21 CFR880.6250 | 21 CFR880.6250 | Same |
| Class | 1 | 1 | Same |
| Intended
Use/Indications for
Use | NITRILE
EXAMINATION
GLOVES (Tested For
Use With
Chemotherapy Drugs)
is a non-sterile
disposable device
intended for medical
purposes that is worn
on the examiner's
hands or finger to
prevent contamination
between patient and
examiner. These gloves
were tested for use with
Chemotherapy Drugs
as per ASTM
D6978-05(2023)
Standard Practice for
Assessment of Medical
Gloves to Permeation
by Chemotherapy | NITRILE
EXAMINATION
GLOVES is a
non-sterile disposable
device intended for
medical purposes that is
worn on the examiner's
hands or finger to
prevent contamination
between patient and
examiner. | Different
Analysis 1 |
| | Drugs. | | |
| Material | Nitrile | Nitrile | Same |
| Powder Free | Yes | Yes | Same |
| Design Feature | Ambidextrous | Ambidextrous | Same |
| Color | Blue | White/Cobalt
Blue/Black/Blue | Different
Analysis 2 |
| Size | S/M/L/XL | S/M/L/XL | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| Rx Only or OTC | OTC | OTC | Same |
| Chemotherapy
Drugs Claim | The following
chemotherapy drugs
and concentration had
NO breakthrough
detected up to 240
minutes, and can be
used with the device.
Cyclophosphamide
(20.0 mg/ml)
Doxorubicin HCl (2.0
mg/ml)
Etoposide (20.0 mg/ml)
Fluorouracil (50.0
mg/ml)
Paclitaxel (6.0 mg/ml)
Cisplatin (1.0 mg/ml)
Dacarbazine (10.0
mg/ml) | No chemotherapy drugs
claim | Different
Analysis 1 |
| | The following
chemotherapy drugs
have low permeation
times:
Carmustine (3.3 mg/ml): 15 minutes
ThioTEPA (10.0 mg/ml): 97 minutes
Warning: Not for Use with: Carmustine, ThioTEPA | | |
| Labeling
Information | Single-use indication,
powder free, device color, device name,
glove size and quantity,
Non-Sterile, applicable
chemotherapy drugs
and the minimum
breakthrough time | Single-use indication,
powder free, device
color, device name,
glove size and quantity,
Non-Sterile
Different
Analysis 1 | |
| Technological Characteristic and Biocompatibility Comparison | | | |
| Dimensions -
Length | S: ≥220mm
M/L/XL: ≥230mm
Meet the requirement
of ASTM D6319-19 | S: ≥220mm
M/L/XL: ≥230mm
Meet the requirement
of ASTM D6319-19
Same | |
| Dimensions -
Width | S: 80±10 mm
M: 95±10 mm
L: 110±10 mm | S: 80±10 mm
M: 95±10 mm
L: 110±10 mm
Same | |
| | Meet the requirement
of ASTM D6319-19 | Meet the requirement
of ASTM D6319-19 | |
| Physical
Properties -
Tensile Strength | before aging ≥14 Mpa
after aging ≥14 Mpa | before aging ≥14 Mpa
after aging ≥14 Mpa | Same |
| | Meet the requirement
of ASTM D6319-19 | Meet the requirement
of ASTM D6319-19 | |
| | | | |
| Physical
Properties -
Ultimate
Elongation | before aging ≥500 %
after aging ≥400 % | before aging ≥500 %
after aging ≥400 % | Same |
| | Meet the requirement
of ASTM D6319-19 | Meet the requirement
of ASTM D6319-19 | |
| | | | |
| Thickness | Palm: ≥0.05 mm
Finger: ≥0.05 mm | Palm: ≥0.05 mm
Finger: ≥0.05 mm | Same |
| | Meet the requirement
of ASTM D6319-19 | Meet the requirement
of ASTM D6319-19 | |
| | | | |
| Powder Free
Residue | ≤2.0mg per glove | ≤2.0mg per glove | Same |
| | Meet the requirement
of ASTM D 6124
following ASTM
D6319-19 | Meet the requirement
of ASTM D 6124
following ASTM
D6319-19 | |
| | | | |
| Freedom from
holes | Be free from holes
when tested in
accordance with ASTM
D5151 following
ASTM D6319-19
AQL=2.5 | Be free from holes
when tested in
accordance with ASTM
D5151 following
ASTM D6319-19
AQL=2.5 | Same |
| | | | |
| | | | |
| Biocompatibility | ISO 10993-5
Under conditions of the
study, device extract is
cytotoxic | ISO 10993-5
Under conditions of the
study, device extract is
cytotoxic | Same |
| | | | |
| | | | |
| ISO 10993-10 | ISO 10993-10 | Same | |
| Under the conditions of
the study, not an irritant
or a sensitizer | Under the conditions of
the study, not an irritant
or a sensitizer | | |
| ISO 10993-11 | ISO 10993-11 | Same | |
| Under the condition of
acute systemic toxicity
test, the test article did
not show acute
systemic toxicity in
vivo. | Under the condition of
acute systemic toxicity
test, the test article did
not show acute
systemic toxicity in
vivo. | | |
8
9
10
11
Analysis 1: The subject device has different indications for use to the predicate device, which results in different product codes, that is, the subject device has extra applicable product codes compared with the predicate device. The major difference between the two devices is that the subject device is claimed for use with certain chemotherapy drugs, while the predicate device did not. However, such difference has been tested according to FDA recognized standard - ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs, which ensures that the subject device will be as safe as for use as the predicate device. Meanwhile, chemotherapy drugs and the minimum breakthrough time of subject device will be listed on labeling, so this different will not bring new concerns regarding safety and effectiveness.
Analysis 2: The subject device is offered only in a single color (Blue) whereas the predicate is offered in different colors (White/Cobalt Blue/Black/Blue), but the color of the subject device is included by those of the predicate device, so such difference will not bring questions regarding safety and effectiveness.
12
10.0 Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
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 D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application.
ASTM D6978-05(2023) Standard Practice for Assessment of Medical Gloves to
Permeation by Chemotherapy Drugs.
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.
ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical | ||
| Dimensions Test | Length: | ||
| S: $\geq$ 220mm | Length: | ||
| S: $\geq$ 220mm | |||
| M/L/XL: $\geq$ 230mm | M/L/XL: $\geq$ 230mm | ||
| Width: | |||
| S: 80 $\pm$ 10 mm | |||
| M: 95 $\pm$ 10 mm | |||
| L: 110 $\pm$ 10 mm | |||
| XL: 120 $\pm$ 10 mm | Width: | ||
| S: 84-86/Pass | |||
| M: 96-102/Pass | |||
| L: 104-107/Pass | |||
| XL: 114-116/Pass | |||
| Thickness: | Thickness: |
Table 2: Summary of non-clinical performance testing
13
| | | Palm: ≥0.05 mm
Finger: ≥0.05 mm | Finger:
0.09-0.11/Pass
Palm:
0.07-0.08/Pass |
|--------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D5151
ASTM D6319 | Watertightness
Test for
Detection of
Holes | Meet the requirements
of ASTM D5151 AQL
2.5 | 0/125/Pass |
| ASTM D6124
ASTM D6319 | Powder Content | Meet the requirement
of ASTM D 6124
≤2.0mg | 0.16-0.19mg/Pass |
| ASTM D412
ASTM D6319 | Physical
Properties | Tensile Strength:
before aging ≥14 Mpa
after aging ≥14 Mpa
Ultimate Elongation:
before aging ≥500 %
after aging ≥400 % | Tensile Strength:
before aging:
20-24Mpa
after aging:
15-23Mpa
Ultimate
Elongation:
before aging:
501-598%
after aging:
471-561% |
| ASTM D6978 | Chemotherapy
drug claim | The chemotherapy
drugs and
concentration which
have NO breakthrough
detected up to 240 | The following
chemotherapy
drugs and
concentration had
NO breakthrough |
| | minutes can be
suggested for use with
the subject device. | detected up to 240
minutes, and can be
used with the
device.
Cyclophosphamide
(20.0 mg/ml)
Doxorubicin HCl
(2.0 mg/ml)
Etoposide (20.0
mg/ml)
Fluorouracil (50.0
mg/ml)
Paclitaxel (6.0
mg/ml)
Cisplatin (1.0
mg/ml)
Dacarbazine (10.0
mg/ml)
The following
chemotherapy
drugs have low
permeation times:
Carmustine (3.3
mg/ml): 15 minutes
ThioTEPA (10.0
mg/ml): 97 minutes
Warning: Not for | |
| | | | Use with: |
| | | | Carmustine, |
| | | | ThioTEPA |
| ISO 10993-5 | Cytotoxicity | toxicity | Under conditions
of the study, device
extract is cytotoxic. |
| ISO 10993-10 | Irritation | Non-irritating | Under the
conditions of the
study, not an
irritant. / Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under the
conditions of the
study, not an
sensitizer. / Pass |
| ISO 10993-11 | Acute Systemic
Toxicity | Non-acute systemic | Under the
conditions of the
study, did not show
acute systemic
toxicity in vivo. /
Pass |
14
15
Table 3 Chemotherapy Permeation Testing Claim
| Chemotherapy Drug | Minimum Breakthrough Detection Time
(Minutes) |
|-------------------------------|--------------------------------------------------|
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Cisplatin (1.0 mg/ml) | >240 |
16
| Dacarbazine (10.0 mg/ml) | >240 |
|---|---|
| Carmustine (3.3 mg/ml) | 15 |
| ThioTEPA (10.0 mg/ml) | 97 |
11.0 Summary of Clinical Testing
Clinical testing is not needed for this device.
12.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K220343.