(259 days)
Not Found
No
The device is a disposable medical glove, and the description and performance studies focus on material properties and barrier function, with no mention of AI or ML.
No
This device, the Skybreeze Zero Nitrile Powder-Free Exam Glove, is described as a disposable exam glove intended to prevent contamination between patient and examiner. Its function is protective, not therapeutic; it does not treat or cure a disease or condition.
No
The device, Skybreeze Zero Nitrile Powder-Free Exam Glove, is described as a disposable exam glove intended to prevent contamination, and its performance studies relate to physical properties and resistance to chemotherapy drugs, not to diagnosing medical conditions.
No
The device is a physical medical glove, not a software-only device. The description details the material, physical properties, and testing of a tangible product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as a "disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection during medical examinations.
- 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.
- Device Description: The description details the physical characteristics of a glove, not a device used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the glove (holes, strength, chemotherapy drug resistance, biocompatibility), not on the accuracy or reliability of diagnostic test results.
The device is a medical glove, which is a type of medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Skybreeze Zero Nitrile Powder-Free 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 the following chemotherapy drugs:
• Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes
• Doxorubicin HCl (2.0 mg/ml) No breakthrough up to 240 minutes
• Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes
• 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes
• Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes
• Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes
• Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes
• Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes
• Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes
• Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes
• Carmustine (3.3 mg/ml) No breakthrough up to 18.6 minutes
• ThioTEPA (10.0 mg.ml) No breakthrough up to 48.3 minutes
Warning: Not for Use with: Carmustine, ThioTEPA
Product codes (comma separated list FDA assigned to the subject device)
LZA, LZC
Device Description
The SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs are disposable, blue-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves packed in a cardboard dispenser box. The Device follows consensus standards: · ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves · ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications · ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves · ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs · ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for Systemic Toxicity · ISO 10993-10: 2010: Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
On the examiner's hand
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)
Study Type: Performance testing based on ASTM standards.
Key Results:
- ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs: Meets acceptance criteria for 10 drugs. No breakthrough up to 240 minutes for Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubicin HCL, Etoposide, Fluorouracil, Ifosfamide, Mitoxantrone, Paclitaxel, Vincristine Sulfate. Carmustine (3.3 mg/ml) showed no signs of breakthrough until 18.6 minutes. Thiotepa (10 mg/ml) showed no signs of breakthrough until 48.3 minutes.
- ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves: Meets the 2.5% AQL requirement for leakage.
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves: Residual powder is an average of 0.4 mg/glove, meeting the powder-free limit of
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 26, 2019
O & M Halyard, Inc. Angela Bunn Director Regulatory Affairs 5405 Windward Parkway Alpharetta, Georgia 30004
Re: K182851
Trade/Device Name: SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I Product Code: LZA, LZC Dated: May 23, 2019 Received: May 24, 2019
Dear Angela Bunn:
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 Elizabeth Claverie-Williams, M.S. Assistant Director THT4B2: Disinfection, Reprocessing and Personal Protection Acting Assistant Director. THT4B1: Sterility Devices 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) K182851
Device Name
SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use with Chemotherapy Drugs
Indications for Use (Describe)
The Skybreeze Zero Nitrile Powder-Free 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 the following chemotherapy drugs:
| Tested Chemotherapy Drugs and Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|
| • Cyclophosphamide (20.0 mg/ml) | No breakthrough up to 240 minutes |
| • Doxorubicin HCl (2.0 mg/ml) | No breakthrough up to 240 minutes |
| • Etoposide (20.0 mg/ml) | No breakthrough up to 240 minutes |
| • 5-Fluorouracil (50.0 mg/ml) | No breakthrough up to 240 minutes |
| • Paclitaxel (Taxol) (6.0 mg/ml) | No breakthrough up to 240 minutes |
| • Cisplatin (1.0 mg/ml) | No breakthrough up to 240 minutes |
| • Dacarbazine (10.0 mg/ml) | No breakthrough up to 240 minutes |
| • Ifosfamide (50.0 mg/ml) | No breakthrough up to 240 minutes |
| • Mitoxantrone (2.0 mg/ml) | No breakthrough up to 240 minutes |
| • Vincristine sulfate (1.0 mg/ml) | No breakthrough up to 240 minutes |
| • Carmustine (3.3 mg/ml) | No breakthrough up to 18.6 minutes |
| • ThioTEPA (10.0 mg.ml) | No breakthrough up to 48.3 minutes |
| Warning: Not for Use with: Carmustine, ThioTEPA |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
| Date Summary
| was Prepared | June 25, 2019 |
|---|---|
| 510(k) Submitter | O & M Halyard, Inc. |
| 5405 Windward Parkway | |
| Alpharetta, GA 20004 | |
| Primary Contact for | |
| this 510(k) Submission | Angela L. Bunn, Director Regulatory Affairs |
| O & M Halyard, Inc. | |
| 5405 Windward Parkway, Alpharetta, GA 30004 US | |
| (470) 448-5158 [voice] | |
| angela.bunn@hyh.com | |
| Device Trade Name | SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for Use |
| with Chemotherapy Drugs | |
| Device Common Name | Medical Exam Gloves |
| Device Product Code | |
| and Classification Name | LZA, LZC |
| Class I, 21 CFR §880.6250 | |
| Patient Examination Glove | |
| Predicate Device | K180646 |
| Halyard Lavender Nitrile Powder-Free Exam Gloves Tested for Use | |
| with Chemotherapy Drugs | |
| Subject Device Description | The SkyBreeze Zero Nitrile Powder-Free Exam Gloves, Tested for |
| Use with Chemotherapy Drugs are disposable, blue-colored, | |
| chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, | |
| non-sterile patient examination gloves packed in a cardboard | |
| dispenser box. The Device follows consensus standards: | |
| · ASTM D5151-06 Standard Test Method for Detection of Holes in | |
| Medical Gloves | |
| · ASTM D6319-10 Standard Specification for Nitrile Examination | |
| Gloves for Medical Applications | |
| · ASTM D6124-06 Standard Test Method for Residual Powder on | |
| Medical Gloves | |
| · ASTM D6978-05 Standard Practice for Assessment of Resistance | |
| of Medical Gloves to Permeation by Chemotherapy Drugs | |
| · ISO 10993-11:2017, Biological evaluation of medical devices - | |
| Part 11: Tests for Systemic Toxicity | |
| · ISO 10993-10: 2010: Biological evaluation of medical devices - | |
| Part 10: Tests for Irritation and Skin Sensitization | |
| Indications for Use | The Skybreeze Zero Nitrile Powder-Free 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 the following chemotherapy drugs: | |
| Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCI (2.0 mg/ml) No breakthrough up to 240 minutes Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) No breakthrough up to 18.6 minutes ThioTEPA (10.0 mg.ml) No breakthrough up to 48.3 minutes Warning: Not for Use with: Carmustine, ThioTEPA | |
| Summary of comparison of | |
| technological characteristics | Both the subject device and the predicate device are powder-free non-sterile |
| nitrile exam gloves tested for resistance to permeation by chemotherapy | |
| drugs. |
4
| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| Subject Device | Predicate Device K180646 | Comparison | |
| FDA Product Code | LZC, LZA | LZC, LZA | Same |
| FDA Classification | Class I | Class I | Same |
| Regulation Number | 880.6250 | 880.6250 | Same |
| Common Name | Medical Exam Glove | Medical Exam Glove | Same |
| Device Trade Name | SkyBreeze Zero Nitrile Powder- | ||
| Free Exam Gloves Tested for | |||
| Use with Chemotherapy Drugs | Halyard Lavender Nitrile Powder- | ||
| Free Exam Gloves Tested for Use | |||
| with Chemotherapy Drugs | Similar | ||
| Intended Use | The Skybreeze Zero Nitrile | ||
| Powder-Free 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 listed on the | |||
| label. | The Halyard Lavender Nitrile- | ||
| Powder-Free 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 listed on the label. | Same | ||
| Technological | |||
| Characteristics | Blue-colored, 9.5-inch, 0.07 mm | ||
| thick at palm, nitrile, powder-free, | |||
| textured fingertip, ambidextrous, | |||
| non- sterile patient examination | |||
| glove. | Lavender-colored, 9.5-inch, .058 | ||
| mm thick at palm, nitrile, powder- | |||
| free, textured fingertip, | |||
| ambidextrous, non- sterile patient | |||
| examination glove. | Similar | ||
| Sizes of gloves | Extra Small (XS) | ||
| Small (S) | |||
| Medium (M) | |||
| Large (L) | |||
| Extra Large (XL) | Extra Small (XS) | ||
| Small (S) | |||
| Medium (M) | |||
| Large (L) | |||
| Extra Large (XL) | Similar | ||
| dimensions | |||
| with minor | |||
| differences in | |||
| fingers and | |||
| palm | |||
| thickness. | |||
| Thickness at Fingers | 0.10 mm (XS) | ||
| 0.10 mm (S) | |||
| 0.10 mm (MS) | |||
| 0.10 mm (L) | |||
| 0.10 mm (XL) | 0.078 mm (XS) | ||
| 0.078 (S) | |||
| 0.078 mm (MS) | |||
| 0.078 mm (L) | |||
| 0.078 mm (XL) | thickness. | ||
| Thickness at Palm | 0.07 mm (XS) | ||
| 0.07 mm (S) | |||
| 0.07 mm (M) | |||
| 0.07 mm (L) | |||
| 0.07 mm (XL) | 0.058 (XS) | ||
| 0.058 (S) | |||
| 0.058 (M) | |||
| 0.058 (L) | |||
| 0.058 (XL) | |||
| Width of Palm | 70 mm (XS) | ||
| 80 mm (S) | |||
| 95 mm (M) | |||
| 110 mm (L) | |||
| 120 mm (XL) | 70 mm (XS) | ||
| 80 mm (S) | |||
| 95 mm (M) | |||
| 110 mm (L) | |||
| 120 mm (XL) | |||
| Length of Palm | 240 mm (XS) | ||
| 240 mm (S) | |||
| 240 mm (M) | |||
| 240 mm (L) | |||
| 240 mm (XL) | 242 mm (XS) | ||
| 242 mm (S) | |||
| 242 mm (M) | |||
| 242 mm (L) | |||
| 242 mm (XL) | |||
| Texture | Textured fingertips | Textured fingertips | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Shelf life | No Shelf life is being claimed at | ||
| this time. | No Shelf life is being claimed at | ||
| this time. | Same | ||
| Biocompatibility | Based ISO 10993 – 11 (2017) | ||
| Biological evaluation of Medical | |||
| devices - Test for Systemic | |||
| Toxicity, the test article was | |||
| considered non-toxic. | Based ISO 10993 – 11 (2017) | ||
| Biological evaluation of Medical | |||
| devices - Test for Systemic | |||
| Toxicity, the test article was | |||
| considered non-toxic. | Same | ||
| Based on ISO 10993 – 10 | |||
| (2010): Under the conditions of | |||
| the study, not a primary skin | |||
| irritant; | |||
| Under conditions of the study, | |||
| not a contact sensitizer. | Based on ISO 10993 – 10 (2010): | ||
| Under the conditions of the study, | |||
| not a primary skin irritant; | |||
| Under conditions of the study, not | |||
| a contact sensitizer. |
5
6
7
| Performance Data | |||
|---|---|---|---|
| Standard | Results | ||
| Subject Device | Results | ||
| K180646 | Remarks | ||
| ASTM D6978-05 | |||
| Standard Practice for | |||
| Assessment of Resistance of | |||
| Medical Gloves to | |||
| Permeation by | |||
| Chemotherapy Drugs | Result: Meets acceptance | ||
| criteria for 10 drugs. | Result: Meets acceptance | ||
| criteria for 10 drugs. | Similar with different | ||
| breakthrough times | |||
| for Carmustine and | |||
| Thiotepa. | |||
| No breakthrough up to 240 | |||
| minutes: | No breakthrough up to | ||
| 240 minutes: | |||
| Cisplatin (1 mg/ml) No | |||
| breakthrough up to 240 | |||
| minutes | Cisplatin (1 mg/ml) No | ||
| breakthrough up to 240 | |||
| minutes | |||
| Cyclophosphamide (20 | |||
| mg/ml) No breakthrough up | |||
| to 240 minutes | Cyclophosphamide (20 | ||
| mg/ml) No breakthrough | |||
| up to 240 minutes | |||
| Dacarbazine (10 mg/ml) | |||
| No breakthrough up to 240 | |||
| minutes | Dacarbazine (10 mg/ml) | ||
| No breakthrough up to | |||
| 240 minutes | |||
| Doxorubicin HCL (2 mg/ml) | |||
| No breakthrough up to 240 | |||
| minutes | Doxorubicin HCL (2 | ||
| mg/ml) No breakthrough | |||
| up to 240 minutes | |||
| Etoposide (20 mg/ml) No | |||
| breakthrough up to 240 | |||
| minutes | Etoposide (20 mg/ml) No | ||
| breakthrough up to 240 | |||
| minutes | |||
| Fluorouracil (50 mg/ml) No | |||
| breakthrough up to 240 | |||
| minutes | Fluorouracil (50 mg/ml) | ||
| No breakthrough up to | |||
| 240 minutes | |||
| Ifosfamide (50 mg/ml) No | |||
| breakthrough up to 240 | |||
| minutes | Ifosfamide (50 mg/ml) No | ||
| breakthrough up to 240 | |||
| minutes | |||
| Mitoxantrone (2 mg/ml) No | |||
| breakthrough up to 240 | |||
| minutes | Mitoxantrone (2 mg/ml) | ||
| No breakthrough up to | |||
| 240 minutes | |||
| Paclitaxel (6 mg/ml) No | |||
| breakthrough up to 240 | |||
| minutes | Paclitaxel (6 mg/ml) No | ||
| breakthrough up to 240 | |||
| minutes | |||
| Vincrinstine Sulfate (1 | |||
| mg/ml) No breakthrough up | |||
| to 240 minutes | Vincrinstine Sulfate (1 | ||
| mg/ml) No breakthrough | |||
| up to 240 minutes | |||
| Carmustine (3.3 mg/ml) | |||
| showed no signs of | |||
| breakthrough until 18.6 | |||
| minutes | Carmustine (3.3 mg/ml) | ||
| showed no signs of | |||
| breakthrough until 0.3 | |||
| minutes | |||
| Thiotepa (10 mg/ml) | |||
| showed no signs of | |||
| breakthrough until 48.3 | |||
| minutes | Thiotepa (10 mg/ml) | ||
| showed no signs of | |||
| breakthrough until 30.9 | |||
| minutes. | |||
| ASTM D5151-06 | |||
| Standard Test Method for | |||
| Detection of Holes in Medical | |||
| Gloves | Testing of the subject | ||
| device shows it meets the | |||
| 2.5% AQL requirement in | |||
| the standards for leakage. | |||
| The device meets the | |||
| acceptance criteria of the | |||
| standard. | Testing of the subject | ||
| device shows it meets the | |||
| 2.5% AQL requirement in | |||
| the standards for leakage. | |||
| The device meets the | |||
| acceptance criteria of the | |||
| standard. | Same | ||
| ASTM D6124-06 | |||
| Standard Test Method for | |||
| Residual Powder on Medical | |||
| Gloves | Residual powder on the | ||
| subject device is an | |||
| average of 0.4 mg/glove | |||
| within the powder-free limit | |||
| of |