(152 days)
Not Found
No
The device is a medical examination glove, and the summary describes standard physical and chemical testing, with no mention of AI or ML.
No
The device is a medical examination glove, which is a barrier to prevent contamination, not a device designed to treat or alleviate a disease or condition.
No
The device is a medical glove, which is a barrier to prevent contamination, not a tool for diagnosing medical conditions.
No
The device is a physical glove made of nitrile butadiene rubber, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that this device is a "powder-free patient examination glove" worn on the hand or finger to prevent contamination between the patient and examiner. Its purpose is a physical barrier, not to analyze biological samples.
- Intended Use: The intended use is for "medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a barrier function, not a diagnostic one.
- Testing: While the gloves are tested for permeation by chemotherapy drugs and Fentanyl, this testing is to ensure the glove's barrier integrity and safety for the user, not to diagnose a condition in a patient.
The information provided consistently describes a medical device used for protection and barrier purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min) |
|---|---|
| Carmustine (BCNU), 3.3 mg/ml | 33.3 |
| Cisplatin, 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan). 20.0 mg/ml | > 240 |
| Cytarabine Hydrochloride, 100 mg/ml | > 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 |
| Daunorubicin, 5 mg/ml | > 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 |
| Etoposide (Toposar), 20.0 mg/ml | > 240 |
| Fluorouracil, 50.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Methotrexate, 25.0 mg/ml | > 240 |
| Mitomycin C, 0.5 mg/ml | > 240 |
| Mitoxantrone, 2mg/ml | > 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 |
| Thiotepa, 10.0 mg/ml | 66.2 |
| Vincristine Sulfate, 1.0 mg/ml | > 240 |
| Fentanyl Citrate, 100mcg/2mL | > 240 |
Please note the following drugs have low permeation times: Carmustine (BCNU) (3.3mg/ml) 33.3 minutes Thiotepa (10.0mg/ml) 66.2 minutes
Warning: Do not use these gloves with Carmustine or Thiotepa
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, OPJ, QDO
Device Description
The Nitrile Medical Examination Glove is a non-sterile, single-use, disposable glove intended for medical purposes to be worn on the hands of examiners to prevent contamination between an examiner and the patient. The gloves are made of nitrile butadiene rubber and are white-colored and powder-free. The gloves are offered in one version in a range of sizes: x-small, small, medium, large, and x-large.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands / hand or finger
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)
Non-clinical testing was performed to demonstrate that the proposed device meets requirements.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10 | Irritation | Not a skin irritant | The subject device is non-irritating |
| ISO 10993-10 | Skin Sensitivity | Not a skin sensitizer | The subject device is non-sensitizing |
| ISO 10993-5 | Cytotoxicity | No cytotoxic reactivity | Failed |
| ISO 10993-11 | Acute Systemic Toxicity | No systemic reactivity | Pass |
| ASTM D6978 | Permeation of Chemotherapy Drugs | >=240 minutes breakthrough time | Pass |
| ASTM D6978 | Permeation of Fentanyl | >=240 minutes breakthrough time | Pass |
| ASTM D6124 | Powder Residue | 2 mg/glove maximum | Pass |
| ASTM D5151 | Pinhole Test | Free from holes, AQL 1.5 | Pass |
| ASTM D6319 | Physical Properties | Before aging Tensile strength: Min. 14 MPa Elongation: Min. 500% After aging Tensile strength: Min. 14 MPa Elongation: Min. 400% | Pass |
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). On the left is the Department of Health & Human Services logo. To the right of that 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.
August 10, 2021
American Performance Polymers, LLC % Natalie Vollrath Sr. Regulatory Consultant MEDIcept, Inc. 200 Homer Avenue Ashland, Massachusetts 01721
Re: K210730
Trade/Device Name: Nitrile Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I. reserved Product Code: LZA, LZC, OPJ, QDO Dated: Jun 23, 2021 Received: Jun 24, 2021
Dear Natalie Vollrath:
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.
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
1
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 (OS) 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, 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210730
Device Name Nitrile Patient Examination Glove
Indications for Use (Describe)
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Test Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time (Min) |
|---|---|
| Carmustine (BCNU), 3.3 mg/ml | 33.3 |
| Cisplatin, 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan). 20.0 mg/ml | > 240 |
| Cytarabine Hydrochloride, 100 mg/ml | > 240 |
| Dacarbazine (DTIC), 10.0 mg/ml | > 240 |
| Daunorubicin, 5 mg/ml | > 240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | > 240 |
| Etoposide (Toposar), 20.0 mg/ml | > 240 |
| Fluorouracil, 50.0 mg/ml | > 240 |
| Ifosfamide, 50.0 mg/ml | > 240 |
| Methotrexate, 25.0 mg/ml | > 240 |
| Mitomycin C, 0.5 mg/ml | > 240 |
| Mitoxantrone, 2mg/ml | > 240 |
| Paclitaxel (Taxol), 6.0 mg/ml | > 240 |
| Thiotepa, 10.0 mg/ml | 66.2 |
| Vincristine Sulfate, 1.0 mg/ml | > 240 |
| Fentanyl Citrate, 100mcg/2mL | > 240 |
Please note the following drugs have low permeation times: Carmustine (BCNU) (3.3mg/ml) 33.3 minutes Thiotepa (10.0mg/ml) 66.2 minutes
Warning: Do not use these gloves 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
CONTINUE ON A SEPARA
3
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
(per 21 CFR 807.92)
1.0 Submitter/510(k) Holder
American Performance Polymers, LLC 23 Gould Street Colebrook, NH 03576
Contact Person: Natalie Vollrath Sr. Requlatory Consultant MEDIcept, Inc. (916) 695-5190 nvollrath@medicept.com
Date Prepared: August 5, 2021
2.0 Device Name
| Proprietary Name: | Pilgrim Nitrile Medical Examination Glove |
|---|---|
| Common Name: | Powder-Free Nitrile Patient Examination Glove |
| Classification Name: | Polymer Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Product Code: | LZA, LZC, OPJ, QDO |
| Classification Panel: | General Hospital |
| Device Classification: | Class I, reserved |
3.0 Predicate Device
K192954 - Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (21CFR 880.6250, Product Code: LZA, LZC, QDO)
4.0 Device Description
The Nitrile Medical Examination Glove is a non-sterile, single-use, disposable glove intended for medical purposes to be worn on the hands of examiners to prevent contamination between an examiner and the patient. The gloves are made of nitrile butadiene rubber and are white-colored and powder-free. The gloves are offered in one version in a range of sizes: x-small, small, medium, large, and x-large.
5
5.0 Intended Use/Indications for Use
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time
(Minutes) |
|---------------------------------------|--------------------------------------------------|
| Carmustine (BCNU) 3.3 mg/ml | 33.3 |
| Cisplatin 1.0 mg/ml | > 240 |
| Cyclophosphamide (Cytoxan) 20.0 mg/ml | > 240 |
| Cytarabine 100 mg/ml | > 240 |
| Dacarbazine 10.0 mg/ml | > 240 |
| Daunorubicin HCI 5.0 mg/ml | > 240 |
| Doxorubicin HCI 2.0 mg/ml | > 240 |
| Etoposide 20.0 mg/ml | > 240 |
| Fluorouracil 50.0 mg/ml | > 240 |
| Ifosfamide 50.0 mg/ml | > 240 |
| Methotrexate 25.0 mg/ml | > 240 |
| Mitoxantrone 2mg/ml | > 240 |
| Paclitaxel (Taxol) 6.0 mg/ml | > 240 |
| Thiotepa 10.0 mg/ml | 66.2 |
| Vincristine Sulfate 1.0 mg/ml | > 240 |
| Fentanyl Citrate 100mcg/2mL | > 240 |
|---|---|
| ----------------------------- | ------- |
Please note the following drugs have low permeation times: Carmustine (BCNU) (3.3mg/ml) 33.3 minutes Thiotepa (10.0mg/ml) 66.2 minutes
Warning: Do not use these gloves with Carmustine or Thiotepa
6.0 Technological Characteristics and Substantial Equivalence
The Nitrile Patient Examination Gloves are summarized within the the following table comparing technological characteristics to the ASTM of the subject gloves to the predicate device.
6
| | Proposed Device
K210730 | Predicate Device
K192954 | Comparison |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device Classification Name | Patient Examination Glove | Patient Examination Glove | Same |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Product Code | LZA, LZC, OPJ, QDO | LZA, LZC, QDO | Similar |
| Intended Use | The Nitrile Patient Examination Glove, non-sterile and powder-free is a disposable device intended for medical purposed that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these gloves have been tested for permeation and breakthrough resistance against various types of chemotherapy drugs and Fentanyl Citrate | The Blue Colored, Powder Free Nitrile Examination Gloves, Non-sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between examiner and patient. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs and Fentanyl Citrate | Similar |
| Prescription v. OTC | OTC | OTC | Same |
| Dimension | Length-XS >229mm, S, M, L, XL >239mm Thickness palm and finger- >0.075mm | Length-Min 240mm Thickness palm and finger- Min 0.05mm | Similar |
| ASTM D6319 - 10 | Palm width:
XS 70 ± 10mm
S 80 ± 10mm
M 95 ± 10mm
L 110 ± 10mm
XL 120 ± 10mm | ------ | Different |
| | Proposed Device
K210730 | Predicate Device
K192954 | Comparison |
| Physical Properties
ASTM D6319 - 10 | Meets | Meets | Same |
| Thickness - Finger, Palm
ASTM D6319 - 10 | Meets | Meets | Same |
| Powder Content
ASTM - D6124 - 06
(≤2 mg/glove) | Meets | Meets | Same |
| Chemotherapy Drug Permeation Test ASTM D6978-05 | | | |
| Chemotherapy Drug
with Concentration: | Minimum Breakthrough Detection Time
(Min.) | | |
| Cisplatin 1.0 mg/ml | >240 | >240 | Same |
| Cyclophosphamide
(Cytoxan) 20.0 mg/ml | >240 | >240 | Same |
| Cytarabine 100 mg/ml | >240 | --- | Different |
| Dacarbazine 10.0 mg/ml | >240 | >240 | Same |
| Daunorubicin HCI 5.0
mg/ml | >240 | --- | Different |
| Doxorubicin HCI 2.0
mg/ml | >240 | >240 | Same |
| Etoposide 20.0 mg/ml | >240 | >240 | Same |
| Fluorouracil 50.0 mg/ml | >240 | >240 | Same |
| Ifosfamide 50.0 mg/ml | >240 | >240 | Same |
| Methotrexate 25.0 mg/ml | >240 | --- | Different |
| Mitoxantrone 2mg/ml | >240 | >240 | Same |
| Paclitaxel (Taxol) 6.0
mg/ml | >240 | >240 | Same |
| Vincristine Sulfate 1.0
mg/ml | >240 | >240 | Same |
| | Proposed Device | Predicate Device | Comparison |
| | K210730 | K192954 | |
| Carmustine (BCNU) 3.3 mg/ml | 33.3 | 18.2 | Similar |
| Thiotepa 10.0 mg/ml | 66.2 | 57.3 | Similar |
| Warning Statement | Please note that the following drugs have low permeation times
Carmustine (BCNU): 33.3 minutes and
Thiotepa: 66.2 minutes
Warning: Do not use with Carmustine or
Thiotepa | * WARNING
Please note that the following drugs have extremely low permeation times
Carmustine (BCNU): 18.2 minutes and
Thiotepa: 57.3 minutes | Similar |
| Fentanyl Citrate Permeation Test ASTM D6978-05 | | | |
| With Concentration: | Minimum Breakthrough Detection Time
(Min.) | | |
| Fentanyl Citrate
100mcg/2mL | >240 | >240 | Same |
| Biocompatibility:
Irritation
ISO 10993-10 | Passes
Under the conditions of the study, the
subject device is non-irritating | Passes
Under the conditions of the study, the
subject device is non-irritating | Same |
| Biocompatibility:
Skin Sensitization
ISO 10993-10 | Passes
Under the conditions of the study, the
subject device is non-sensitizing | Passes
Under the conditions of the study, the
subject device is non-sensitizing | Same |
| | Proposed Device
K210730 | Predicate Device
K192954 | Comparison |
| Biocompatibility:
Cytotoxicity
ISO 10993-5 | Exhibits severe
cytotoxicity reactivity
at 100% | Exhibits severe
cytotoxicity reactivity
at 100%, and 66%
extract
concentrations and
no cytotoxicity
reactivity at 44%,
30%, 20% and 15%
extract
concentrations under
the condition of this
test | Similar |
| Biocompatibility:
Acute Systemic Toxicity
ISO 10993-11 | Passes
Additional acute
systemic toxicity
testing results
showed no systemic
toxicity concern | Passes
Under the conditions
of the study, the
subject showed no
adverse biological
reaction | Similar |
| Pinhole Test | Passes | Passes | Same |
| Material | Nitrile | Nitrile | Same |
| Color | White | Blue | Different |
| Size | Extra Small
Small
Medium
Large
Extra Large | Extra Small
Small
Medium
Large
Extra Large | Same |
| Sterile v. Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Single-Use v. Reusable | Single-Use | Single-Use | Same |
7
8
9
The Chemotherapy claim is similar to the predicate, which has a glove thickness that complies with the ASTM Standards. Compared with the predicate, the subject device was tested with additional chemotherapy drugs.
10
7.0 Performance Testing
Non-clinical testing was performed to demonstrate that the proposed device meets requirements.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10 | Irritation | Not a skin irritant | The subject device is |
| non-irritating | |||
| ISO 10993-10 | Skin Sensitivity | Not a skin sensitizer | The subject device is |
| non-sensitizing | |||
| ISO 10993-5 | Cytotoxicity | No cytotoxic reactivity | Failed |
| ISO 10993-11 | Acute Systemic | ||
| Toxicity | No systemic reactivity | Pass | |
| ASTM D6978 | Permeation of | ||
| Chemotherapy Drugs | ≥240 minutes | ||
| breakthrough time | Pass | ||
| ASTM D6978 | Permeation of | ||
| Fentanyl | ≥240 minutes | ||
| breakthrough time | Pass | ||
| ASTM D6124 | Powder Residue | 2 mg/glove maximum | Pass |
| ASTM D5151 | Pinhole Test | Free from holes, AQL | |
| 1.5 | Pass | ||
| ASTM D6319 | Physical Properties | Before aging | |
| Tensile strength: | |||
| Min. 14 MPa | |||
| Elongation: Min. | |||
| 500% | |||
| After aging | |||
| Tensile strength: Min. | |||
| 14 MPa | |||
| Elongation: Min. | |||
| 400% | Pass |
8.0 Conclusion
Results from non-clinical performance testing to applicable standards demonstrate that the proposed Pilgrim Gloves are as safe and effective as the legally marketed predicate gloves.