(30 days)
Not Found
No
The device is a standard examination glove and the summary contains no mention of AI or ML capabilities.
No.
The device is described as a "patient examination glove" intended to prevent contamination between patient and examiner, not to treat a medical condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function.
No
The device description clearly states it is a physical examination glove made of nitrile, which is a hardware component. The testing described also focuses on the physical properties and performance of the glove.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "patient examination glove" worn on the hand to "prevent contamination between patient and examiner." This is a barrier device for personal protection and infection control.
- Device Description: The description reinforces this, detailing a physical glove made of nitrile for examination purposes.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This glove does not perform any such analysis or provide diagnostic information based on bodily specimens.
- Testing: The testing described focuses on the physical properties of the glove (strength, holes, powder) and its resistance to chemotherapy drugs, which are relevant to its barrier function and safety for the user, not to diagnostic testing of patient samples.
The information provided clearly indicates this is a medical device intended for barrier protection, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Cloves to Permeation by Chemotherapy Drugs.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ
Device Description
The Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) is a non-sterile, single use only, disposable examination glove intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are nitrile, powder free, and blue in color. They feature an ambidextrous design with textured fingertips, straight fingers, and a beaded cuff. The gloves are available in sizes small, medium, large, and extralarge, packaged in a chipboard box.
The gloves are designed and manufactured in accordance with ASTM D6319-19 and tested for use with chemotherapy drugs per ASTM D6978-05(2019).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner / Medical purposes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The biocompatibility evaluation for the Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) was conducted in accordance with ANSI/AAMI/ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by the FDA: and ISO 10993-12:2012, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials, with deviations from Clause 11 without negative impact on testing as documented in Section 018 Performance Testing - Bench.
The following tests were performed to evaluate the biocompatibility of the Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) to show substantial equivalence to the predicate device:
- ISO 10993-5:2009 Cytotoxicity
- ISO 10993-10:2010 Primary Skin Sensitization
- ISO 10993-10:2010 Dermal Sensitization
- ISO 10993-11:2017 Systemic Toxicity
Physical performance qualities of the proposed device were evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. Permeation 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 range of chemotherapy drugs.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (2017), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D6978-05 (2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Key Results:
- The proposed device is potentially cytotoxic under the conditions of the study.
- The proposed device is a non-irritant and a non-sensitizer under the conditions of the study.
- The proposed device does not elicit a systemic toxicity response in the model animal under the conditions of the study.
- The device complies with all referenced ASTM standards for physical properties, dimensions, freedom from holes (AQL 2.5), and residual powder (
§ 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.
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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, 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.
April 29, 2021
Harbour Health LLC % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K210944
Trade/Device Name: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ Dated: March 28, 2021 Received: March 30, 2021
Dear Dave Yungvirt:
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.
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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.
Clarence W. Murray III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs)
Indications for Use (Describe)
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. Gloves have been tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Cloves to Permeation by Chemotherapy Drugs.
Chemotherapy Drug Permeation:
| No. | Chemotherapy Drug Tested | Concentration | Breakthrough Detection Time (Minutes |
|---|---|---|---|
| 1 | Busulfan | 6 mg/ml (6,000 ppm) | > 240 |
| 2 | Carboplatin | 10 mg/ml (10,000 ppm) | > 240 |
| 3 | Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 14.5* |
| 4 | Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 |
| 5 | Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | > 240 |
| 6 | Cytarabine | 100 mg/ml (100,000 ppm) | > 240 |
| 7 | Dacarbazine | 10.0 mg/ml (10,000 ppm) | > 240 |
| 8 | Docetaxel | 10 mg/ml (10,000 ppm) | > 240 |
| 9 | Doxorubicin HCI | 2.0 mg/ml (2,000 ppm) | > 240 |
| 10 | Etoposide | 20.0 mg/ml (20,000 ppm) | > 240 |
| 11 | Fluorouracil | 50.0 mg/ml (50,000 ppm) | > 240 |
| 12 | Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 |
| 13 | Mechlorethamine HCI | 1 mg/ml (1,000 ppm) | > 240 |
| 14 | Methotrexate | 25 mg/ml (25,000 ppm) | > 240 |
| 15 | Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 |
| 16 | Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 |
| 17 | Paclitaxel | 6.0 mg/ml (6,000 ppm) | > 240 |
| 18 | Thiotepa | 10.0 mg/ml (10,000 ppm) | 47.4* |
| 19 | Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | > 240 |
- WARNING: Not recommended for use with Carmustine and Thiotepa.
The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times:
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 14.5 minutes |
|---|---|---|
| Thiotepa | 10.0 mg/ml (10,000 ppm) | 47.4 minutes |
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.
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Image /page/4/Picture/0 description: The image shows the logo for Harbour Health. The logo consists of a yellow symbol on the left and the words "HARBOUR HEALTH" on the right. The symbol is made up of two vertical lines with a dotted cross in the middle.
510(k) Summary
510(k) Summary [As required by 21 CFR 807.92(c)] K210944
Submitter / 510(k) Sponsor Harbour Health LLC 4590 MacArthur Boulevard, Suite 500 Newport Beach, CA 92660
Registration Number: 3017153466
Contact Person Jared Koenig CEO Tel: (949) 629-5068 Email: jared@factorydirecthealth.com
Summary Preparation Date 19 April 2021
Type of 510(k) Submission Traditional
Device Name / Classification Trade Name: Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) Common Name: Non-powdered patient examination glove Classification Name: Medical Gloves with Chemotherapy Labeling Claims - Test For Use with Chemotherapy Drugs Product Code: LZA, LZC, OPJ Review Panel: General Hospital Regulatory Class: Class 1 Regulation Number: 21 CFR 880.6250 Predicate Device Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Device Name: Drugs (Blue) 510(k) Number: K182600
510(k) Owner: Better Care Plastic Technology Co., Ltd
Device Description
The Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) is a non-sterile, single use only, disposable examination glove intended for medical purposes to be worn by examiners to prevent contamination between the examiner. The gloves are nitrile, powder free, and blue in color. They feature an ambidextrous design with textured fingertips,
Harbour Health LLC 4590 MacArthur Boulevard. Suite 500 Newport Beach, CA 92660
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Image /page/5/Picture/0 description: The image shows the logo for Harbour Health. The logo consists of a stylized "H" formed by two vertical lines with a series of dots in the center, resembling a plus sign. To the right of the symbol, the words "HARBOUR HEALTH" are written in a simple, sans-serif font.
straight fingers, and a beaded cuff. The gloves are available in sizes small, medium, large, and extralarge, packaged in a chipboard box.
The gloves are designed and manufactured in accordance with ASTM D6319-19 and tested for use with chemotherapy drugs per ASTM D6978-05(2019).
Indications for Use
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.
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 Tested | Concentration | Breakthrough Detection
Time (Minutes) |
|----------------------------|-------------------------|------------------------------------------|
| Busulfan | 6 mg/ml (6,000 ppm) | > 240 |
| Carboplatin | 10 mg/ml (10,000 ppm) | > 240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 14.5* |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | > 240 |
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | > 240 |
| Cytarabine | 100 mg/ml (100,000 ppm) | > 240 |
| Dacarbazine | 10.0 mg/ml (10,000 ppm) | > 240 |
| Docetaxel | 10 mg/ml (10,000 ppm) | > 240 |
| Doxorubicin HCI | 2.0 mg/ml (2,000 ppm) | > 240 |
| Etoposide | 20.0 mg/ml (20,000 ppm) | > 240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | > 240 |
| Ifosfamide | 50 mg/ml (50,000 ppm) | > 240 |
| Mechlorethamine HCI | 1 mg/ml (1,000 ppm) | > 240 |
| Methotrexate | 25 mg/ml (25,000 ppm) | > 240 |
| Mitomycin C | 0.5 mg/ml (500 ppm) | > 240 |
| Mitoxantrone | 2 mg/ml (2,000 ppm) | > 240 |
| Paclitaxel | 6.0 mg/ml (6,000 ppm) | > 240 |
| Thiotepa | 10.0 mg/ml (10,000 ppm) | 47.4* |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | > 240 |
Table 1: Chemotherapy Drug Permeation
- WARNING: Not recommended for use with Carmustine and Thiotepa.
The maximum testing time is 240 minutes. Please note that the following drugs have low permeation times:
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | 14.5 minutes |
|---|---|---|
| Thiotepa | 10.0 mg/ml (10,000 ppm) | 47.4 minutes |
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Image /page/6/Picture/1 description: The image shows the logo for Harbour Health. The logo consists of a yellow symbol on the left and the words "HARBOUR HEALTH" on the right. The symbol is made up of two vertical lines with a plus sign in the middle, formed by small yellow dots.
Summary of Technological Characteristics
| Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Device Name | Harbour Health Powder Free
Nitrile Examination Glove, Blue
(Tested for Use with
Chemotherapy Drugs) | Powder Free Nitrile Examination
Glove, Tested for Use with
Chemotherapy Drugs (Blue) | N/A |
| 510(k) Reference | K210944 | K182600 | N/A |
| Product Owner | Harbour Health LLC | Better Care Plastic Technology
Co., Ltd. | N/A |
| Product Code | LZA, LZC, OPJ | LZA, LZC | Similar |
| Intended Use | The Harbour Health Powder Free
Nitrile Examination Glove, Blue
(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. The proposed device
was tested for use with
chemotherapy drugs per ASTM
D6978-05(2019), Standard Practice
for Assessment of Medical Gloves
to Permeation by Chemotherapy
Drugs | Powder Free Nitrile Examination
Gloves, Tested for Use with
Chemotherapy Drugs (Blue) is a
disposable device intended for
medical purposes that is worn on
the examiner's hand to prevent
contamination between patient and
examiner. Gloves have been tested
for use with chemotherapy drugs
using ASTM D6978-05(2013) and
will be labeled with a statement of
compliance and a summary of the
testing results. Chemotherapy Drug
Permeation. | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material | Nitrile | Nitrile | Same |
| Color | Blue | Blue | Same |
| Design Features | Ambidextrous
Textured fingertips
Beaded cuff
Straight fingers | Ambidextrous | Similar |
| Sizes | Small, Medium, Large, Extra
Large | Extra Small, Small, Medium,
Large, Extra Large | Same |
| Rx vs OTC | OTC | OTC | Same |
| Sterile vs Non-
Sterile | Non-Sterile | Non-Sterile | Same |
| Disposable vs Non-
Disposable | Disposable | Disposable | Same |
| Single Use vs
Reusable | Single Use | Single Use | Same |
| Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
| Dimensions - Width | Complies with ASTM D6319-19
Small:
80 ±
10mm
Medium:
95 ±
10mm
Large:
110 ±
10mm
Extra Large:
120 ±
10mm | Complies with ASTM D6319-19
Extra Small:
70 ±
10mm
Small:
80 ±
10mm
Medium:
95 ±
10mm
Large:
110 ±
10mm
Extra Large:
120 ±
10mm | Same |
| Dimensions -
Thickness | Complies with ASTM D6319-19
Palm:
0.05mm
min.
Finger:
0.05mm
min. | Complies with ASTM D6319-19
Palm:
0.05mm
min.
Finger:
0.05mm
min. | Same |
| Dimensions - Length | Complies with ASTM D6319-19
Small:
220mm min.
Medium/Large/Extra Large:
| Complies with ASTM D6319-19
Small: 220mm min.
Medium/Large/Extra Large:
230mm min. | Similar |
| Physical Properties -
Tensile Strength | Complies with ASTM D6319-19
Before Aging:
$\ge$ 14 MPa,
min.
After Aging:
$\ge$ 14 MPa,
min. | Complies with ASTM D6319-19
Before Aging:
$\ge$ 14 MPa,
min.
After Aging:
$\ge$ 14 MPa,
min. | Same |
| Physical Properties -
Elongation | Complies with ASTM D6319-19
Before Aging:
500%
min.
After Aging:
400%
min. | Complies with ASTM D6319-19
Before Aging:
500%
min.
After Aging:
400%
min. | Same |
| Freedom from Holes | Complies with ASTM D6319-19
and ASTM D5151-19
G-1, AQL 2.5 | In accordance with ASTM D 5151-
06, following ASTM D6319- 10,
G-1, AQL 2.5 | Similar |
| Powder or Powder
Free | Powder Free | Powder Free | Same |
| Residual Powder | Complies with ASTM D6319-19
$\le$ 2 mg per glove | In accordance with ASTM D6124-
06 (Reapproved 2017), following
ASTM D6319-10
$\le$ 2 mg per glove | Same |
| Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
| Biocompatibility | Complies with ANSI/AAMI/ISO
10993-5 (2009)
• Under the conditions of the
study, the device is potentially
cytotoxic.
Complies with ANSI/AAMI/ISO
10993-10 (2010)
• Under the conditions of the
study, the device is a non-
irritant and a non-sensitizer.
Complies with ANSI/AAMI/ISO
10993-11 (2017)
• Under the conditions of the
study, the device does not elicit
a systemic toxicity response in
the model animal. | Complies with ANSI/AAMI/ISO
10993-10 (2010)
• Not a skin irritant
• Not a skin sensitizer | Similar |
| Chemotherapy Drugs Tested with Minimum Breakthrough Detection Time as tested
per ASTM D6978-05 (2019) | | | |
| Bleomycin | Not tested | 15.0 mg/ml (15,000 ppm)
240 minutes | Different |
| Busulfan | 6.0 mg/ml (6,000 ppm)
240 minutes | 6.0 mg/ml (6,000 ppm)
240 minutes | Same |
| Carboplatin | 10.0 mg/ml (10,000 ppm)
240 minutes | 10.0 mg/ml (10,000 ppm)
240 minutes | Same |
| Carmustine
(BCNU) | 3.3 mg/ml (3,300 ppm)
14.5 minutes | 3.3 mg/ml (3,300 ppm)
11.0 minutes | Same |
| Chloroquine | Not tested | 50.0 mg/ml (50,000 ppm)
240 minutes | Different |
| Cisplatin | 1 mg/ml (1,000 ppm)
240 minutes | 1 mg/ml (1,000 ppm)
240 minutes | Same |
| Cyclophosphamide
(Cytoxan) | 20 mg/ml (20,000 ppm)
240 minutes | 20 mg/ml (20,000 ppm)
240 minutes | Same |
| Cyclosporin | Not tested | 100.0 mg/ml (100,000 ppm)
240 minutes | Different |
| Cytarabine | 100.0 mg/ml (100,000 ppm)
240 minutes | 100.0 mg/ml (100,000 ppm)
240 minutes | Same |
| Dacarbazine | 10 mg/ml (10,000 ppm)
240 minutes | 10 mg/ml (10,000 ppm)
240 minutes | Same |
| Daunorubicin | Not tested | 5.0 mg/ml (5,000 ppm)
240 minutes | Different |
| Docetaxel | 10.0 mg/ml (10,000 ppm)
240 minutes | 10.0 mg/ml (10,000 ppm)
240 minutes | Same |
| Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
| Doxorubicin HCI | 2 mg/ml (2,000 ppm)
240 minutes | 2 mg/ml (2,000 ppm)
240 minutes | Same |
| Epirubicin
(Ellence) | Not tested | 2.0 mg/ml (2,000 ppm)
240 minutes | Different |
| Etoposide | 20 mg/ml (20,000 ppm)
240 minutes | 20 mg/ml (20,000 ppm)
240 minutes | Same |
| Fludarabine | Not tested | 25.0 mg/ml (25,000 ppm)
240 minutes | Different |
| Fluorouracil | 50 mg/ml (50,000 ppm)
240 minutes | 50 mg/ml (50,000 ppm)
240 minutes | Same |
| Gemcitabine
(Gemzar) | Not tested | 38.0 mg/ml (38,000 ppm)
240 minutes | Different |
| Idarubicin | Not tested | 1.0 mg/ml (1,000 ppm)
240 minutes | Different |
| Ifosfamide | 50.0 mg/ml (50,000 ppm)
240 minutes | 50.0 mg/ml (50,000 ppm)
240 minutes | Same |
| Irinotecan | Not tested | 20.0 mg/ml (20,000 ppm)
240 minutes | Different |
| Mechlorethamine
HCI | 1.0 mg/ml (1,000 ppm)
240 minutes | 1.0 mg/ml (1,000 ppm)
240 minutes | Same |
| Melphalan | Not tested | 5.0 mg/ml (5,000 ppm)
240 minutes | Different |
| Methotrexate | 25 mg/ml (25,000 ppm)
240 minutes | 25 mg/ml (25,000 ppm)
240 minutes | Same |
| Mitomycin C | 0.5 mg/ml (500 ppm)
240 minutes | 0.5 mg/ml (500 ppm)
240 minutes | Same |
| Mitoxantrone | 2.0 mg/ml (2,000 ppm)
240 minutes | 2.0 mg/ml (2,000 ppm)
240 minutes | Same |
| Oxaliplatin | Not tested | 2.0 mg/ml (2,000 ppm)
240 minutes | Different |
| Paclitaxel | 6 mg/ml (6,000 ppm)
240 minutes | 6 mg/ml (6,000 ppm)
240 minutes | Same |
| Paraplatin | Not tested | 10.0 mg/ml (10,000 ppm)
240 minutes | Different |
| Retrovir | Not tested | 10.0 mg/ml (10,000 ppm)
240 minutes | Different |
| Rituximab | Not tested | 10.0 mg/ml (10,000 ppm)
240 minutes | Different |
| Thiotepa | 10 mg/ml (10,000 ppm)
47.4 minutes | 10 mg/ml (10,000 ppm)
28.8 minutes | Same |
| Topotecan HCL | Not tested | 1.0 mg/ml (1,000 ppm)
240 minutes | Different |
| Characteristic | Proposed Device | Predicate Device | Comparison
Analysis |
| Trisonex | Not tested | 1.0 mg/ml (1,000 ppm)
240 minutes | Different |
| Velcade
(Bortezomib) | Not tested | 1.0 mg/ml (1,000 ppm)
240 minutes | Different |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm)
240 minutes | 1.0 mg/ml (1,000 ppm)
240 minutes | Same |
Table 2: Comparison of Proposed and Predicate Devices
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Summary of Non-Clinical Testing
The biocompatibility evaluation for the Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) was conducted in accordance with ANSI/AAMI/ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by the FDA: and ISO 10993-12:2012, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials, with deviations from Clause 11 without negative impact on testing as documented in Section 018 Performance Testing - Bench.
The following tests were performed to evaluate the biocompatibility of the Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) to show substantial equivalence to the predicate device:
| • ISO 10993-5:2009 | Cytotoxicity |
|---|---|
| • ISO 10993-10:2010 | Primary Skin Sensitization |
| • ISO 10993-10:2010 | Dermal Sensitization |
| • ISO 10993-11:2017 | Systemic Toxicity |
Summary of Performance Testing (Bench)
Physical performance qualities of the proposed device were evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. Permeation 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 range of chemotherapy drugs.
In summary, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- . ASTM D5151-19, Standard Test Method for Detection of Holes in Medical Gloves
- . ASTM D6124-06 (2017), Standard Test Method for Residual Powder on Medical Gloves
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical ● Application
- ASTM D6978-05 (2019), Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
Conclusion
In accordance with 21 CFR Part 807 and based on the non-clinical testing and information provided in this premarket notification, Harbour Health LLC concludes that the Harbour Health Powder Free Nitrile Examination Glove, Blue (Tested for Use with Chemotherapy Drugs) is as safe, as effective, and
Harbour Health LLC 4590 MacArthur Boulevard. Suite 500 Newport Beach, CA 92660
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performs as well as the legally marketed predicate device, Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (K182600).
Additionally, both the LZA and LZC/OPJ gloves meet the FDA-recognized consensus standards, all labeling claims, and the pinhole acceptable quality level (AQL).