(109 days)
Not Found
No
The device is a physical examination glove and the summary does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The testing described is for physical and chemical properties of the glove.
No
The device is described as a medical glove worn by an examiner to prevent contamination, not to treat or alleviate a medical condition.
No
The device is a medical glove intended for preventing contamination between patient and examiner, not for diagnosing a condition or disease.
No
The device description clearly states it is a physical glove made of nitrile, and the performance studies focus on physical and chemical properties of the glove material. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. These tests are performed outside the body (in vitro).
- Device's Intended Use: The intended use of this device is clearly stated as a "powder-free patient examination glove... worn on the examiner's hand to prevent contamination between patient and examiner." This is a barrier device used during patient examination, not a device used to perform tests on samples.
- Device Description: The description reinforces its function as a physical barrier worn on the hand.
- Performance Studies: The performance studies focus on the physical properties of the glove (dimensions, strength, hole detection, powder) and its ability to prevent permeation of certain substances (chemotherapy drugs, fentanyl). These are not studies related to diagnostic testing of biological samples.
The testing for chemotherapy drugs and fentanyl permeation is related to the glove's protective function as a barrier, not its use in diagnosing a condition.
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 to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.
The list of Chemotherapy Drugs tested (with breakthrough times) are as follows:
- CAUTION: Testing showed an average breakthrough time of 25.5 min for Carmustine and 47.7 min for ● Thiotepa.
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC, QDO
Device Description
The Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing was conducted to demonstrate that the Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves met all required design specifications. The test results demonstrated that the proposed device did meet the performance criteria as specified utilizing the following test method standards and specifications:
- ISO 10993-10:2010 (2014) Irritation - Pass – Under the conditions of the study, the subject device is not a primary skin irritant.
- ISO 10993-10:2010 (2014) Sensitization - Pass - Under the conditions of the study, the subject device is not a primary skin sensitizer.
- ISO 10993-5:2009 (2014) Cytotoxicity - Fail – Under the conditions of the study, the subject device is cytotoxic.
- ISO 10993-11:2017 Acute Systemic Toxicity - Pass - Under the conditions of the study, the subject device is not toxic.
- ASTM D6319-19 ASTM D3767-03 (2020) Physical Dimensions - Pass
- ASTM D6978-05 (2019) Permeation of Fentanyl - Pass
- ASTM D6978-05 (2019) Permeation of Chemotherapy Drugs - Pass
- ASTM D5151-19 Detection of Holes - Pass
- ASTM D6124-06 (2017) Residual Powder - Pass
- ASTM D6319-19 ASTM D412-16 (2021) ASTM D573-04 (2019) Physical Properties - 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration" in a larger font and the word "Administration" in a smaller font.
July 8, 2022
American Nitrile Operations LLC Stephen Perrin Manager of Quality Assurance & Regulatory Affairs 3500 Southwest Blvd Grove City, Ohio 43123
Re: K220825
Trade/Device Name: Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA, LZC, QDO Dated: June 8, 2022 Received: June 13, 2022
Dear Stephen Perrin:
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,
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220825
Device Name
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
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 to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.
The list of Fentanyl and Chemotherapy Drugs tested (with breakthrough times) are:
| Chemotherapy Drug and Concentration | Breakthrough Time (minutes) |
|---|---|
| Carmustine (BNCU) (3.3 mg/ml) | 25.5 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| 5-Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 47.7 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Fentanyl (100mcg/2ml) | >240 |
CAUTION: Testing showed an average breakthrough time of 25.5 min for Carmustine and 47.7 min for Thiotepa.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
K220825
AMERICAN NITRILE OPERATIONS LLC SAPPHIRE PRO POWDER-FREE ROYAL BLUE NITRILE EXAM GLOVES
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Image /page/4/Picture/0 description: The image shows the words "AMERICAN NITRILE" in large, bold, blue font. The words are all capitalized and evenly spaced. The background is white, which makes the blue text stand out. The text appears to be the name of a company.
Image /page/4/Picture/1 description: The image shows a logo of a stylized bird with its wings spread. The bird's body and head are red, while the wings are blue with a grid pattern. The logo has a modern and abstract design, with clean lines and a symmetrical composition. The bird's wings are angled upwards, suggesting flight or progress.
510(k) Summary
(In accordance with 21 CFR 807.92)
Submitter
American Nitrile Operations LLC 3500 Southwest Blvd Grove City, OH 43123
Contact Person: Stephen R Perrin Jr Manager of Quality Assurance and Regulatory Affairs sperrin@aamericannitrile.com
Summary Preparation Date
08 JUN 2022
Type of 510(k) Submission
Abbreviated
Device Name & Classification
| Device Name & Classification | |
|---|---|
| Trade Name | Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves |
| Common Name | Non-powdered patient examination glove |
| Classification Name | Nitrile Blue Chemo and Fentanyl Tested Patient Examination Gloves |
| Product Code | LZA, LZC, QDO |
| Review Panel | General Hospital |
| Regulatory Class | Class I |
| Regulation Number | 21 CFR 880.6250 |
| Predicate Device | |
|---|---|
| Device Name | Medline Powder-Free Orange Nitrile Patient Examination Gloves |
| (Tested for use with Fentanyl) | |
| 510k Number | K200150 |
| 510k Owner | Medline Industries, Inc. |
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Image /page/5/Picture/1 description: The image shows a logo with a stylized eagle design. The eagle's head and upper body are depicted in red, while the wings are blue with a grid-like pattern. The overall design is symmetrical and modern, with clean lines and a bold color scheme.
Device Description:
The Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves are non-sterile, single use, disposable gloves intended for medical purposes to be worn on the hands of examiners to prevent contamination between a patient and an examiner. The gloves are nitrile, powder-free, ambidextrous, and blue-colored with a beaded cuff. The range of sizes includes small, medium, large, and extra-large.
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 to prevent contamination between patient and examiner. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment for Medical Gloves to Permeation by Chemotherapy Drugs.
| Fentanyl and Chemotherapy Drug Permeation Resistance | ||
|---|---|---|
| Drug Tested | Concentration | Breakthrough Detection Time (minutes) |
| Carmustine (BNCU) | 3.3 mg/ml | 25.5 |
| Cyclophosphamide | 20.0 mg/ml | >240 |
| Doxorubicin HCl | 2.0 mg/ml | >240 |
| Etoposide | 20.0 mg/ml | >240 |
| 5-Fluorouracil | 50.0 mg/ml | >240 |
| Methotrexate | 25.0 mg/ml | >240 |
| Paclitaxel | 6.0 mg/ml | >240 |
| Thiotepa | 10.0 mg/ml | 47.7 |
| Vincristine Sulfate | 1.0 mg/ml | >240 |
| Fentanyl Citrate | 100mcg/2ml | >240 |
The list of Chemotherapy Drugs tested (with breakthrough times) are as follows:
- CAUTION: Testing showed an average breakthrough time of 25.5 min for Carmustine and 47.7 min for ● Thiotepa.
Summary of Technological Characteristics
The technological characteristics of the Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves are summarized within the following table comparing subject gloves to the predicate device under ASTM or equivalent standards:
| Device Characteristic | Proposed Device
K220825 | Predicate Device
K200150 | Comparison
Analysis |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Product Name | Sapphire Pro Powder-Free
Royal Blue Nitrile Exam
Gloves | Medline Powder-Free Orange
Nitrile Patient Examination
Gloves (Tested for use with
Fentanyl) | N/A |
| Product Code | LZA, LZC, QDO | LZA, QDO | Similar |
| Intended Use | A powder-free patient
examination glove is a
disposable device intended | A patient examination glove
is a disposable device
intended for medical purposes | Similar |
| Device Characteristic | Proposed Device
K220825 | Predicate Device
K200150 | Comparison
Analysis |
| | for medical purposes that is
worn on the examiner's hand
to prevent contamination
between patient and
examiner. The glove was
tested for use with
Chemotherapy Drugs and
Fentanyl Citrate as per
ASTM D6978-05 Standard
Practice for Assessment for
Medical Gloves to
Permeation by Chemotherapy
Drugs. | that is worn on the
examiner's hand to prevent
contamination between
patient and examiner. These
gloves were Tested for use
with Fentanyl Citrate as per
ASTM D6978-05
(Reapproved 2019) | |
| Regulation Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Material Composition | Synthetic Nitrile Rubber | Powder free Nitrile | Same |
| Color | Blue | Orange | Different |
| Sizes | Small, Medium, Large, Extra-
Large | Small, Medium, Large, Extra-
Large, Extra-Extra Large | Similar |
| Dimensions - Length | Meets Requirements of
ASTM D6319-19:
220 mm minimum | Meets Requirements of
ASTM D6319-19:
220 mm minimum | Same |
| Dimensions - Width | Meets Requirements of
ASTM D6319-19:
70 mm minimum | Meets Requirements of
ASTM D6319-19:
70 mm minimum | Same |
| Dimensions -
Thickness | Meets Requirements of
ASTM D6319-19:
0.05 mm minimum (Finger or
Palm) | Meets Requirements of
ASTM D6319-19:
0.05 mm minimum (Finger
and Palm) | Same |
| Physical Properties -
Tensile Strength | Complies with: ASTM
D6319-10 minimum:
Tensile Strength:
Before Aging ≥14 MPa. | Complies with: ASTM
D6319-10 minimum:
Tensile Strength:
Before Aging ≥14 MPa. | Same |
| Physical Properties -
Elongation | After Aging ≥14 MPa.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | After Aging ≥14 MPa.
Elongation:
Before Aging 500%, min.
After Aging 400%, min. | |
| Freedom from Holes | Meets Requirements of
ASTM D6319-19 and D5151-
19:
G-1, AQL 2.5 | Meets Requirements of
ASTM D6319-19 and D5151-
19:
G-1, AQL 2.5 | Same |
| Powder or Powder Free | Powder-Free | Powder-Free | Same |
| Residual Powder | Meets Requirements of
ASTM D6319-19 and D6124-
06:
240 min | Fentanyl Citrate 100mcg/2ml
240 min | Same |
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AMERICAN NITRILE
Image /page/6/Picture/1 description: The image shows a logo with a stylized eagle design. The eagle's head and body are outlined in red, while its wings are blue with a grid-like pattern. The overall design is symmetrical and evokes a sense of flight or freedom. The logo is simple, yet striking, with a clear and recognizable shape.
7
AMERICAN NITRILE
Image /page/7/Picture/1 description: The image shows a logo of a stylized bird with its wings spread. The bird's head and upper body are outlined in red, while the wings are filled with blue lines that create a feathered effect. The bird's body is formed by a red, diamond-like shape, and the overall design is symmetrical and modern. The logo is set against a white background, which makes the colors stand out.
Summary of Nonclinical Testing
Non-Clinical Testing was conducted to demonstrate that the Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves met all required design specifications. The test results demonstrated that the proposed device did meet the performance criteria as specified utilizing the following test method standards and specifications:
| Name of Test /
| Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10:2010 | |||
| (2014) | Irritation | Pass / Fail | Pass – Under the conditions of |
| the study, the subject device is | |||
| not a primary skin irritant. |
8
AMERICAN NITRILE
Image /page/8/Picture/1 description: The image shows a logo with a stylized bird design. The bird's head and body are outlined in red, while its wings are blue with a grid-like pattern. The overall design is symmetrical and evokes a sense of flight or aviation.
| Name of Test /
| Standard | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-10:2010 | |||
| (2014) | Sensitization | Pass / Fail | Pass - Under the conditions of |
| the study, the subject device is | |||
| not a primary skin sensitizer. | |||
| ISO 10993-5:2009 | |||
| (2014) | Cytotoxicity | Pass / Fail | Fail – Under the conditions of |
| the study, the subject device is | |||
| cytotoxic. | |||
| ISO 10993-11:2017 | Acute Systemic | ||
| Toxicity | Pass / Fail | Pass - Under the conditions of | |
| the study, the subject device is | |||
| not toxic. | |||
| ASTM D6319-19 | |||
| ASTM D3767-03 | |||
| (2020) | Physical Dimensions | Length: 220 mm min. | |
| Width: 70 mm min. | |||
| Thickness – Palm and | |||
| Finger: 0.05 mm min. | Pass | ||
| ASTM D6978-05 | |||
| (2019) | Permeation of Fentanyl | 240 minutes breakthrough | |
| time min. | Pass | ||
| ASTM D6978-05 | |||
| (2019) | Permeation of | ||
| Chemotherapy Drugs | 240 minutes breakthrough | ||
| time min. | Pass | ||
| ASTM D5151-19 | Detection of Holes | Leakage detection, AQL | |
| 2.5 | Pass | ||
| ASTM D6124-06 | |||
| (2017) | Residual Powder | Max 2.0 mg / glove | Pass |
| ASTM D6319-19 | |||
| ASTM D412-16 (2021) | |||
| ASTM D573-04 (2019) | Physical Properties | Tensile Strength: | |
| Before Aging ≥ 14 MPa, | |||
| min | |||
| After Aging ≥ 14 MPa, min | |||
| Elongation: | |||
| Before Aging 500%, min. | |||
| After Aging 400%, min | Pass |
Conclusion
The conclusions drawn from the nonclinical test demonstrates that the device, Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicate device, the Medline Powder-Free Orange Nitrile Patient Examination Gloves (Tested for use with Fentanyl) – K200150