(92 days)
Not Found
No
The device is a physical examination glove and the summary describes standard physical and chemical resistance testing, with no mention of AI or ML.
No
The device is a disposable exam glove intended to prevent contamination between patient and examiner, not to provide therapy.
No
Explanation: The device is an exam glove designed to prevent contamination between patient and examiner, not to diagnose medical conditions. Its performance tests relate to physical properties and resistance to chemotherapy drugs, not diagnostic capabilities.
No
The device is a physical glove, not software. The description details its material, physical properties, and testing related to those properties and resistance to chemicals.
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 device is "worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier function for personal protection, not a diagnostic test performed on a sample taken from the human body.
- Device Description: The description reinforces that it's a glove for examination purposes, focusing on physical properties and resistance to certain substances.
- Performance Studies: The performance studies focus on the physical characteristics of the glove (dimensions, strength, freedom from holes, powder) and its resistance to chemotherapy drugs. These are tests of the device's barrier properties and material integrity, not diagnostic performance.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVD devices are designed to perform tests on samples (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions. This glove does not perform such a function.
N/A
Intended Use / Indications for Use
Disposable Powder Free Nitrile Exam Glove (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summarized in Table below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration (mg/mL) | Breakthrough time (minutes) |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/mL | 6.2min |
| Cisplatin | 1.0 mg/mL | >240min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | >240min |
| Dacarbazine (DTIC) | 10.0 mg/mL | >240min |
| Doxorubicin HCL (Adriamycin) | 2.0 mg/mL | >240min |
| Etoposide (Toposar) | 20.0 mg/mL | >240min |
| Fluorouracil (Adrucil) | 50.0 mg/mL | >240min |
| Paclitaxel (Taxol) | 6.0 mg/mL | >240min |
| ThioTEPA | 10.0 mg/mL | 8.4min |
| Methotrexate | 25.0 mg/mL | >240min |
| Vincristine sulfate | 1.0 mg/mL | >240min |
Do not use with Carmustine or ThioTEPA.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) 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. The gloves are offered in sizes small, medium, large, extra large packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 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
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)
Study Type: Non-clinical testing, Biocompatibility and Performance Testing.
Sample Size: Not explicitly stated for all tests, but for "Freedom from holes" it states "80 of 80 passed of each size".
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
Biocompatibility Testing:
- ISO 10993-10: Primary Skin Irritation - Results indicate "Not a skin irritant".
- ISO 10993-10: Dermal Sensitization - Results indicate "Not a skin sensitizer".
- ISO 10993-05: Cytotoxicity - Results indicate "Non-Toxic".
- ISO 10993-11: Systemic Toxicity - Results indicate "Non-Toxic".
Performance Testing:
- Dimensions (width) (thickness):
- Purpose: Evaluate the physical dimension of the glove.
- Acceptance Criteria: Width 70mm min; Length 220mm min; Palm – 0.05mm min.; Finger–0.05mm min.
- Results: Pass. 76mm min width; 229mm min length; Palm – 0.07mm min.; Finger–0.08mm min.
- Physical properties:
- Purpose: Evaluate the tensile strength and ultimate elongation before and after aging.
- Acceptance Criteria: Tensile Strength: Before Aging ≥ 14 MPa, min. After Aging ≥ 14 MPa, min. Elongation: Before Aging 500%, min. After Aging 400%, min.
- Results: Pass. Tensile Strength: Before Aging 15.08 MPa, min. After Aging 14.87 MPa, min. Elongation: Before Aging 570%, min. After Aging 529%, min.
- Freedom from holes:
- Purpose: Detect holes in the gloves.
- Acceptance Criteria: No leakage at sampling level of G-1, AQL 2.5.
- Results: Pass. No leakage, 80 of 80 passed of each size.
- Residual Powder:
- Purpose: Detect the powder residue in the glove.
- Acceptance Criteria: 240min for most drugs (with exceptions for Carmustine and ThioTEPA).
- Results:
- Cisplatin: >240min
- Cyclophosphamide (Cytoxan): >240min
- Dacarbazine (DTIC): >240min
- Doxorubicin HCL (Adriamycin): >240min
- Etoposide (Toposar): >240min
- Fluorouracil (Adrucil): >240min
- Paclitaxel (Taxol): >240min
- Methotrexate: >240min
- Vincristine sulfate: >240min
- Carmustine (BCNU): 6.2min (note: "Do not use with Carmustine or ThioTEPA" is specified)
- ThioTEPA: 8.4min (note: "Do not use with Carmustine or ThioTEPA" is specified)
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 11, 2021
CRDLight Optoelectronic Technology Co., Ltd Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K212532
Trade/Device Name: Disposable Powder Free Nitrile Exam 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 Dated: August 11, 2021 Received: August 11, 2021
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 (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 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.
For Clarence W. Murray III, PhD 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) K212532
Device Name
Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)
Indications for Use (Describe)
Disposable Powder Free Nitrile Exam Glove (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summarized in Table below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration (mg/mL) | Breakthrough time (minutes) |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/mL | 6.2min |
| Cisplatin | 1.0 mg/mL | >240min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | >240min |
| Dacarbazine (DTIC) | 10.0 mg/mL | >240min |
| Doxorubicin HCL (Adriamycin) | 2.0 mg/mL | >240min |
| Etoposide (Toposar) | 20.0 mg/mL | >240min |
| Fluorouracil (Adrucil) | 50.0 mg/mL | >240min |
| Paclitaxel (Taxol) | 6.0 mg/mL | >240min |
| ThioTEPA | 10.0 mg/mL | 8.4min |
| Methotrexate | 25.0 mg/mL | >240min |
| Vincristine sulfate | 1.0 mg/mL | >240min |
Do not use with Carmustine or 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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3
510(K) Summary
K212532
(As requirement by 21 CFR 807.92)
Date prepared: 2021-11-10
A. Applicant:
Name: CRDLIGHT OPTOELECTRONIC TECHNOLOGY CO., LTD Address: Floor 1-5 BULIDING NO.7 & FLOOR 1-4 BUILDING NO.5 NO.18 XINYI ROAD, JIANGHAI DISTRICT, JIANGMEN GUANGDONG, CHINA Contact: Fishy liang Title: General Manager Tel: +86-13924689685 Email: fishy@gdyanyang.com
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: fda.sungo@gmail.com
B. Device:
Trade Name: Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) Common Name: Non-powdered patient examination glove
Regulatory Information
Classification Name: Medical Gloves with Chemotherapy Labeling Claims – Test For Use with Chemotherapy Drugs Classification: Class I Product code: LZA, LZC Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
C. Predicate device:
K200960
Medline Nitrile Powder-Free Dark Blue Examination Gloves (Tested for use with Chemotherapy Drugs) Medline Industries, Inc.
4
D. Indications for use of the device:
Disposable Powder Free Nitrile Exam Glove (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Summarized in Table 1 below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug | Concentration (mg/mL) | Breakthrough time (minutes) |
|---|---|---|
| Carmustine (BCNU) | 3.3 mg/mL | 6.2min |
| Cisplatin | 1.0 mg/mL | >240min |
| Cyclophosphamide (Cytoxan) | 20.0 mg/mL | >240min |
| Dacarbazine (DTIC) | 10.0 mg/mL | >240min |
| Doxorubicin HCL (Adriamycin) | 2.0 mg/mL | >240min |
| Etoposide (Toposar) | 20.0 mg/mL | >240min |
| Fluorouracil (Adrucil) | 50.0 mg/mL | >240min |
| Paclitaxel (Taxol) | 6.0 mg/mL | >240min |
| ThioTEPA | 10.0 mg/mL | 8.4min |
| Methotrexate | 25.0 mg/mL | >240min |
| Vincristine sulfate | 1.0 mg/mL | >240min |
Do not use with Carmustine or ThioTEPA.
E. Device Description:
The Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) 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. The gloves are offered in sizes small, medium, large, extra large packed in a paper box. The gloves are designed and manufactured in accordance with the ASTM D6319-19 standard and are tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019).
F. Summary of Technological Characteristics
Table 2 Comparison of Proposed and Predicate Devices
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K212532 | K200960 | - |
| Manufacturer | CRDLIGHT OPTOELECTRONIC TECHNOLOGY | ||
| CO., LTD | Medline Industries, Inc. | - |
5
CRDLIGHT OPTOELECTRONIC TECHNOLOGY CO., LTD Floor 1-5 BULIDING NO.7 & FLOOR 1-4 BUILDING NO.5 NO.18 XINYI ROAD, JIANGHAI DISTRICT, JIANGMEN GUANGDONG, CHINA
| Product Name | Disposable Powder Free Nitrile Exam Gloves
(Tested For Use With Chemotherapy Drugs) | Medline Nitrile Powder-Free Dark
Blue Examination Gloves (Tested for
use with Chemotherapy Drugs) | Similar |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | LZA, LZC | LZA, LZC | Same |
| Regulation
Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for
use | Disposable Powder Free Nitrile Exam 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. | 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. | Same |
| Design
configurations | Blue | Dard blue | Similar |
| Material | Nitrile | Nitrile | Same |
| Size | S, M, L, XL | S, M, L, XL, XXL | Similar |
| Contact duration | Limited ≤ 24 hours | Limited ≤ 24 hours | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Singe use | Single use | Same |
| Dimensions | Complies with: ASTM D6319-19 | Complies with: ASTM D6319-10 | Similar |
| Dimensions
(thickness) | Complies with: ASTM D6319-19
Palm – 0.05mm min.
Finger – 0.05mm min. | Complies with: ASTM D6319-10
Palm - 0.05mm min.
Finger - 0.05mm min. | Similar |
| Physical
properties | Complies with: ASTM D6319-19
Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | Complies with: ASTM D6319-10
Tensile Strength:
Before Aging ≥14 MPa, min.
After Aging ≥14 MPa, min.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | Similar |
| Freedom from
holes | Complies with: ASTM D6319-19 and ASTM
D5151-19
G-1, AQL 2.5 | Complies with: ASTM D6319-10 and
ASTM D5151-06
G-1, AQL 1.5 | Different |
| Powder free | Yes | Yes | Same |
| Residual Powder | Complies with: ASTM D6319-19
240min | Cisplatin | 1.0 mg/ml
(1,000 ppm) | >240 minutes |
| | Cyclophosphamide
(Cytoxan) | 20.0 mg/mL | >240min | Cyclophosphamide
(Cytoxan) | 20.0 mg/ml
(20,000 ppm) | >240 minutes |
| | Dacarbazine (DTIC) | 10.0 mg/mL | >240min | Dacarbazine
(DTIC) | 10.0 mg/ml
(10,000 ppm) | >240 minutes |
| | Doxorubicin HCL
(Adriamycin) | 2.0 mg/mL | >240min | Doxorubicin
Hydrochloride | 2.0 mg/ml
(2,000 ppm) | >240 minutes |
| | Etoposide
(Toposar) | 20.0 mg/mL | >240min | Etoposide
(Toposar) | 20.0 mg/ml
(20,000 ppm) | >240 minutes |
| | Fluorouracil
(Adrucil) | 50.0 mg/mL | >240min | Fluorouracil | 50.0 mg/ml
(50,000 ppm) | >240 minutes |
| | Paclitaxel (Taxol) | 6.0 mg/mL | >240min | Methotrexate | 25 mg/ml
(25,000 ppm) | >240 minutes |
| | ThioTEPA | 10.0 mg/mL | 8.4min | Mitomycin C | 0.5 mg/ml (500 ppm) | >240 minutes |
| | Methotrexate | 25.0 mg/mL | >240min | Paclitaxel (Taxol) | 6.0 mg/ml
(6,000 ppm) | >240 minutes |
| | Vincristine sulfate | 1.0 mg/mL | >240min | Thio Tepa | 10.0 mg/ml
(10,000 ppm) | 27.4 minutes |
| | | | | Vincristine Sulfate
(Oncovin) | 1.0 mg/ml
(1,000 ppm) | >240 minutes |
| | Do not use with Carmustine or ThioTEPA. | | | Do Not Use with Carmustine or Thiotepa | | |
G. Summary of Non-Clinical Testing
> 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 A-Limited (≤24h). The following tests for the subject device were conducted to evaluated the biocompatibility of Disposable Powder Free Nitrile Exam Gloves:
- ISO 10993-10: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- · ISO 10993-05: Cytotoxicity
- · ISO 10993-11: Systemic Toxicity
A Performance Testing
Physical performance testing of the proposed device were conducted as per ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application testing was conducted to support the addition of the labeling claim: Tested for use with chemotherapy drugs. In addition, the proposed device was tested according to ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs, in which minimum breakthrough times were determined for a wide range of chemotherapy drugs.
To summarize, the performance testing of the subject device were 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
7
CRDLIGHT OPTOELECTRONIC TECHNOLOGY CO., LTD Floor 1-5 BULIDING NO.7 & FLOOR 1-4 BUILDING NO.5 NO.18 XINYI ROAD, JIANGHAI DISTRICT, JIANGMEN GUANGDONG, CHINA
- 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) | The purpose of the | ||||||||||||||||||||||||||||||||
| test is to evaluate | |||||||||||||||||||||||||||||||||
| the physical | |||||||||||||||||||||||||||||||||
| dimension of the | |||||||||||||||||||||||||||||||||
| glove | Width 70mm min | ||||||||||||||||||||||||||||||||
| Length 220mm min | |||||||||||||||||||||||||||||||||
| Palm – 0.05mm min. | |||||||||||||||||||||||||||||||||
| Finger–0.05mm min. | Pass | ||||||||||||||||||||||||||||||||
| 76mm min width | |||||||||||||||||||||||||||||||||
| 229mm min length | |||||||||||||||||||||||||||||||||
| Pass | |||||||||||||||||||||||||||||||||
| Palm – 0.07mm min. | |||||||||||||||||||||||||||||||||
| Finger–0.08mm min | |||||||||||||||||||||||||||||||||
| Physical properties | 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: | |||||||||||||||||||||||||||||||||
| Before Aging 500%, min. | |||||||||||||||||||||||||||||||||
| After Aging 400%, min. | Pass | ||||||||||||||||||||||||||||||||
| Tensile Strength: | |||||||||||||||||||||||||||||||||
| Before Aging 15.08 MPa, min. | |||||||||||||||||||||||||||||||||
| After Aging 14.87 MPa, min. | |||||||||||||||||||||||||||||||||
| Elongation: | |||||||||||||||||||||||||||||||||
| Before Aging 570%, min. | |||||||||||||||||||||||||||||||||
| After Aging 529%, min. | |||||||||||||||||||||||||||||||||
| Freedom from holes | The purpose of the | ||||||||||||||||||||||||||||||||
| test is to detect | |||||||||||||||||||||||||||||||||
| holes in the gloves | No leakage at | ||||||||||||||||||||||||||||||||
| sampling level of G-1, | |||||||||||||||||||||||||||||||||
| AQL 2.5 | Pass | ||||||||||||||||||||||||||||||||
| No leakage, 80 of 80 passed of each size | |||||||||||||||||||||||||||||||||
| Residual Powder | The purpose of the | ||||||||||||||||||||||||||||||||
| test is to detect the | |||||||||||||||||||||||||||||||||
| powder residue in | |||||||||||||||||||||||||||||||||
| the glove | 240min | Pass Chemotherapy Drug Concentration (mg/mL) Breakthrough time (minutes) Cisplatin 1.0 mg/mL >240min Cyclophosphamide (Cytoxan) 20.0 mg/mL >240min Dacarbazine (DTIC) 10.0 mg/mL >240min Doxorubicin HCL (Adriamycin) 2.0 mg/mL >240min Etoposide (Toposar) 20.0 mg/mL >240min Fluorouracil (Adrucil) 50.0 mg/mL >240min Paclitaxel (Taxol) 6.0 mg/mL >240min Methotrexate 25.0 mg/mL >240min Vincristine sulfate 1.0 mg/mL >240min |
H. Clinical Test Conclusion
8
No clinical study is included in this submission.
l. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Disposable Powder Free Nitrile Exam Glove (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 K200960.