SafeSource Direct Blue Powder-Free Nitrile Exam Gloves

K222898 · Safesource Direct, LLC · LZA · Nov 7, 2022 · General Hospital

Device Facts

• Record ID: K222898
• Device Name: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves
• Applicant: Safesource Direct, LLC
• Product Code: LZA · General Hospital
• Decision Date: Nov 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Story

Disposable, non-sterile, powder-free nitrile examination glove; made of synthetic copolymer of acrylonitrile and butadiene (NBR rubber) with blue dye. Used by healthcare professionals in clinical settings to provide a protective barrier against contamination between patient and examiner. Tested for resistance to chemotherapy drug permeation per ASTM D6978-05. Available in small, medium, large, and extra-large sizes. Device functions as a physical barrier; no active components or software. Benefits include protection against cross-contamination and exposure to hazardous chemotherapy agents during handling.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including physical dimensions (ASTM D6319), watertightness (ASTM D5151), powder content (ASTM D6124), physical properties (ASTM D412), and chemotherapy permeation resistance (ASTM D6978-05). Biocompatibility testing (ISO 10993-5, 10, 11) confirms the device is non-irritating, non-sensitizing, and lacks acute systemic toxicity.

Technological Characteristics

Material: Synthetic copolymer of acrylonitrile and butadiene (NBR rubber). Form factor: Disposable, powder-free, blue-dyed glove. Standards: ASTM D6319-19 (physical properties), ASTM D6978-05 (chemotherapy permeation), ASTM D5151-06 (watertightness), ASTM D6124 (powder content). Biocompatibility: ISO 10993-5, 10, 11. Non-sterile. No energy source or software.

Indications for Use

Indicated for use as a disposable patient examination glove worn on the examiner's hands to prevent contamination between patient and examiner. Suitable for use with specific chemotherapy drugs. Not recommended for use with Carmustine (BCNU) or Thio-Tepa due to low permeation times.

Regulatory Classification

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.

Predicate Devices

• Medline Powder-Free Light Blue Nitrile Exam Gloves (K201390)

Submission Summary (Full Text)

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November 7, 2022

SafeSource Direct, LLC % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K222898

Trade/Device Name: SafeSource Direct Blue Powder-Free 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, OPJ Dated: October 31, 2022 Received: November 1, 2022

Dear Prithul Bom:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Allan Gu

For Bifeng Oian, M.D., 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K222898

Device Name SafeSource Direct Blue Powder-Free Nitrile Exam Gloves

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes Methotrexate 25 mg/ml ≥ 240 Minutes Mitomycin C 0.5 mg/ml ≥ 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Not recommended for use with these drugs.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/2 description: The image contains the logo for SafeSource Direct. The logo consists of a shield with a red background and a blue "S" shape in the center. To the right of the shield is the text "SafeSource" in a bold, sans-serif font. Below "SafeSource" is the word "Direct" in the same font, and below that is the phrase "Personal Protective Equipment" in a smaller, lighter font.

## 510(k) Summary K222898

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the SafeSource Direct Blue Powder-Free Nitrile Exam Gloves Traditional 510(k) premarket notification.

| Sponsor: | SafeSource Direct, LLC<br>200 St Nazaire Rd.<br>Broussard, LA 70518<br>Sponsor Contact: Justin Hollingsworth |
|---------------------|-----------------------------------------------------------------------------------------------------------------|
| Submission Contact: | Grace Powers, MS, MBA, RAC<br>Founder/Principal Consultant<br>Powers Regulatory Consulting<br>Tel: [phone] |
| Preparation Date: | October 30, 2022 |

Subject Device:

Trade Name: SafeSource Direct Blue Powder-Free Nitrile Exam Gloves Common/Usual Name: Non-Powdered Patient Examination Glove Classification Name: Non-Powdered Patient Examination Glove Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC, OPJ Device Class: Class I, Reserved Classification Panel: General Hospital and Personal Use Devices

Predicate Device: Legally marketed device to which substantial equivalence is claimed: Trade/Proprietary Name: Medline Powder-Free Light Blue Nitrile Exam Gloves Manufacturer: Medline Industries, Inc. 510(k): K201390 Common/Usual Name: Non-Powdered Patient Examination Glove Classification Name: Patient Examination Glove, Specialty Classification Regulation: 21 CFR 880.6250 Product Code: LZA, LZC Device Class: Class I, Reserved Classification Panel: General Hospital and Personal Use Devices

#### Device Description

The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves are a patient examination glove that is a non-sterile, single use, disposable device intended for medical purposes that is worn on the examiner's hands to prevent

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#### Traditional 510(k) - SafeSource Direct, LLC SafeSource Direct Blue Powder-Free Nitrile Exam Gloves

contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs. These gloves are made of synthetic copolymer of acrylonitrile and butadiene (NBR rubber) with a blue dye. The gloves are available in small, medium, large, and extra-large.Physical performance of the proposed device were evaluated per ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application (FR Recognition Number 6-446).

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 (FR Recognition Number 6-147).

### Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Cisplatin 1.0 mg/ml ≥ 240 Minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml ≥ 240 Minutes Dacarbazine (DTIC) 10.0 mg/ml ≥ 240 Minutes Doxorubicin Hydrochloride 2.0 mg/ml ≥ 240 Minutes Etoposide (Toposar) 20.0 mg/ml ≥ 240 Minutes Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes Methotrexate 25 mg/ml ≥ 240 Minutes Mitomycin C 0.5 mg/ml ≥ 240 Minutes Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Vincristine Sulfate (Oncovin) 1.0 mg/ml ≥ 240 Minutes

Please note that the following drugs have low permeation times: Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes Thio-Tepa 10.0 mg/ml 87.0 Minutes Not recommended for use with these drugs.

The gloves are available over the counter.

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#### Technological Characteristics

The SafeSource Direct Blue Powder-Free Nitrile Exam Gloves has similar technological characteristics as the predicate device.

| Table 1 – General Comparison | | | |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Comparison | Subject Device:<br>SafeSource Direct Blue<br>Powder-Free Nitrile Exam<br>Gloves<br>(K222898) | Predicate Device:<br>Medline Powder-Free Light<br>Blue Nitrile Exam Gloves<br>(K201390) | Comparison |
| Device | SafeSource Direct Blue<br>Powder-Free Nitrile Exam<br>Gloves | Medline Powder-Free Light<br>Blue Nitrile Exam Gloves | Not Applicable |
| Manufacturer | SafeSource Direct, LLC | Medline Industries, Inc. | Not Applicable |
| FDA Product<br>Code | LZA, LZC, OPJ | LZA, LZC | Identical |
| Regulation<br>Name | Non-powdered Patient<br>Examination<br>Glove, Specialty | Non-powdered Patient<br>Examination<br>Glove, Specialty | Identical |
| Regulation<br>Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Identical |
| Intended Use/<br>Indications for<br>Use | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hands<br>to prevent contamination<br>between patient and<br>examiner. These gloves were<br>tested for use with<br>chemotherapy drugs, as per<br>ASTM D6978-05 (Reapproved<br>2019) Standard Practice for<br>Assessment of Medical Gloves<br>to Permeation by<br>Chemotherapy Drugs.<br>Carmustine (BCNU) 3.3 mg/ml<br>35.8 Minutes<br>Cisplatin 1.0 mg/ml ≥ 240<br>Minutes<br>Cyclophosphamide (Cytoxan)<br>20.0 mg/ml ≥ 240 Minutes<br>Dacarbazine (DTIC) 10.0<br>mg/ml ≥ 240 Minutes<br>Doxorubicin Hydrochloride<br>2.0 mg/ml ≥ 240 Minutes<br>Etoposide (Toposar) 20.0<br>mg/ml ≥ 240 Minutes | A patient examination glove is<br>a disposable device intended<br>for medical purposes that is<br>worn on the examiner's hands<br>to prevent contamination<br>between patient and<br>examiner. These gloves were<br>tested for use with<br>chemotherapy drugs, as per<br>ASTM D6978-05 (Reapproved<br>2019) Standard Practice for<br>Assessment of Medical Gloves<br>to Permeation by<br>Chemotherapy Drugs.<br>Carmustine (BCNU) 3.3 mg/ml<br>25.3 Minutes<br>Cisplatin 1.0 mg/ml ≥ 240<br>Minutes<br>Cyclophosphamide (Cytoxan)<br>20.0 mg/ml ≥ 240 Minutes<br>Dacarbazine (DTIC) 10.0<br>mg/ml ≥ 240 Minutes<br>Doxorubicin Hydrochloride<br>2.0 mg/ml ≥ 240 Minutes<br>Etoposide (Toposar) 20.0<br>mg/ml ≥ 240 Minutes | Identical with<br>the exception of<br>the Carmustine<br>and Thio-Tepa<br>breakthrough<br>times. |
| Device Comparison | Subject Device:<br>SafeSource Direct Blue<br>Powder-Free Nitrile Exam<br>Gloves | Predicate Device:<br>Medline Powder-Free Light<br>Blue Nitrile Exam Gloves<br>(K201390) | Comparison |
| | Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes<br>Methotrexate 25 mg/ml ≥ 240 Minutes<br>Mitomycin C 0.5 mg/ml ≥ 240 Minutes<br>Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes<br>Thio-Tepa 10.0 mg/ml 87.0 Minutes<br>Vincristine Sulfate (Oncovin) 43.7 mg/ml ≥ 240 Minutes<br>Please note that the following drugs have low permeation times:<br>Carmustine (BCNU) 3.3 mg/ml 35.8 Minutes<br>Thio-Tepa 10.0 mg/ml 87.0 Minutes<br>Not recommended for use with these drugs. | Fluorouracil 50.0 mg/ml 0.5 mg/ml ≥ 240 Minutes<br>Methotrexate 25 mg/ml ≥ 240 Minutes<br>Mitomycin C 0.5 mg/ml ≥ 240 Minutes<br>Paclitaxel (Taxol) 6.0 mg/ml ≥ 240 Minutes<br>Thio-Tepa 10.0 mg/ml 43.7 Minutes<br>Vincristine Sulfate (Oncovin) 43.7 mg/ml ≥ 240 Minutes<br>Please note that the following drugs have low permeation times:<br>Carmustine (BCNU) 3.3 mg/ml 25.3 Minutes<br>Thio-Tepa 10.0 mg/ml 43.7 Minutes<br>Caution: Testing showed an average breakthrough time of 43.7 minutes with Thio-Tepa<br>WARNING: Do not use with Carmustine | |
| Sizes | Small, Medium, Large, Extra Large | Extra Small, Small, Medium, Large, Extra Large | Similar- the subject device does not come in extra small. |
| Materials | Nitrile | Nitrile | Similar |
| Color | Blue | Blue | Identical |
| Condition of Use | Single Use (Disposable) | Single Use (Disposable) | Identical |
| Powder or<br>Powder-Free | Powder free | Powder Free | Identical |
| Dimensions-Length | Complies with ASTM D6319-19<br>240mm min. | Complies with ASTM D6319-10<br>240mm min. | Identical |
| Dimensions-Width | Complies with ASTM D6319-19<br>S: 80±10mm<br>M: 95±10mm<br>L: 110±10mm<br>XL: 120±10mm | Complies with ASTM D6319-10<br>XS: N/A<br>S: 85±10mm<br>M: 95±10mm<br>L: 105±10mm | Similar- Both comply with the standard. |
| Device<br>Comparison | Subject Device:<br>SafeSource Direct Blue<br>Powder-Free Nitrile Exam<br>Gloves | Predicate Device:<br>Medline Powder-Free Light<br>Blue Nitrile Exam Gloves<br>(K201390) | Comparison |
| Dimensions-<br>Thickness | Complies with ASTM D6319-19<br>Palm – 0.05 minimum<br>Finger – 0.05 minimum | XL: 115 $\pm$ 10mm<br>Complies with ASTM D6319-10<br>Palm - 0.14<br>Finger - 0.16<br>Cuff - 0.12 | Similar- Both<br>comply with the<br>standard. Cuff<br>was not<br>measured on<br>the subject<br>device. |
| Physical<br>Properties –<br>Tensile Strength | Complies with ASTM D6319-19<br>Tensile Strength:<br>Before Aging $\geq$ 14 Mpa, min<br>After Aging $\geq$ 14 Mpa, min | Complies with ASTM D6319-10<br>Tensile Strength:<br>Before Aging $\geq$ 17 Mpa, min<br>After Aging $\geq$ 14 Mpa, min | Similar- Both<br>comply with the<br>standard. |
| Physical<br>Properties –<br>Elongation | Elongation:<br>Before Aging 500% Min<br>After Aging 400% Min | Elongation:<br>Before Aging 500% Min<br>After Aging 400% Min | Identical |
| Freedom from<br>Holes | Complies with ASTM D6319-19<br>and ASTM D5151-06 G-1, AQL 2.5 | Complies with ASTM D6319-10<br>and ASTM D5151-06 G-1, AQL 2.5 | Identical |
| Residual Powder | Max. 0.42mg per glove | Max. 0.52mg per glove | Identical |
| Biocompatibility | ISO 10993-10<br>ISO 10993-11<br>Not a skin irritant<br>Not a skin sensitizer<br>No clinical sign of<br>acute systemic<br>toxicity | • ISO 10993-10: Primary Skin<br>Irritation, not a skin irritant<br>• ISO 10993-10: Dermal<br>Sensitization, not a skin<br>sensitizer<br>• ISO 10993-11: No clinical sign<br>of acute systemic toxicity | Identical- Both<br>devices are not<br>a skin irritant or<br>skin sensitizer.<br>Both devices<br>showed no<br>clinical sign of<br>acute systemic<br>toxicity |
| Sterility | Non-sterile | Non-sterile | Identical |

### Table 1 – General Comparison

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### Traditional 510(k) – SafeSource Direct, LLC SafeSource Direct Blue Powder-Free Nitrile Exam Gloves

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### Traditional 510(k) – SafeSource Direct, LLC SafeSource Direct Blue Powder-Free Nitrile Exam Gloves

### Non-Clinical Performance Data

## Table 2 - Summary of Non-Clinical Performance Testing

| Test Method | Purpose | Acceptance Criteria | Results |
|-------------|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D6319 | Physical Dimensions<br>Test | Length (mm):<br>S: ≥ 220<br>M/L/XL: ≥ 230<br>Width (mm):<br>S: 80 ± 10<br>M: 95 ± 10<br>L: 110 ± 10<br>XL: 120 ± 10<br>Thickness (mm): | Length (mm):<br>S: ≥ 220 / Pass<br>M/L/XL: ≥ 230 / Pass<br>Width (mm):<br>S: 82 – 85 / Pass<br>M: 95 – 97 / Pass<br>L: 103 – 107 / Pass<br>XL: 110 – 116 / Pass<br>Thickness (mm): |

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### Traditional 510(k) – SafeSource Direct, LLC SafeSource Direct Blue Powder-Free Nitrile Exam Gloves

| | | | Finger: ≥ 0.05<br>Palm: ≥ 0.05 | Finger: 0.13 – 0.17 / Pass<br>Palm: 0.09 – 0.11 / Pass | |
|--------------|-----------------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------|------------------|
| ASTM D5151 | Watertightness Test<br>for Detection of Holes | Meet the requirements of ASTM<br>D5151 AQL 2.5 | S: 1/125 / Pass<br>M: 2/125 / Pass<br>L: 2/125 / Pass<br>XL: 4/125 / Pass | | |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM<br>D6124 < 2.0 mg | 0.4 mg / Pass | | |
| ASTM D412 | Physical Properties | | Tensile Strength | ≥ 14 MPa | 14 – 19 MPa |
| | | Before Aging | Ultimate Elongation | ≥ 500% | 515 – 540% |
| | | | Meet the requirements of ASTM D412 AQL 4.0 | 1/13 / Pass | |
| | | | | | |
| | | After Aging | Tensile Strength | ≥ 14 MPa | 15 – 20 / Pass |
| | | | Ultimate Elongation | ≥ 400% | 468 – 525 / Pass |
| ISO 10993-5 | Cytotoxicity | Non-In Vitro Cytotoxicity | Under conditions of the<br>study, device extract is<br>cytotoxic. | | |
| ISO 10993-11 | Acute Systemic Toxicity | Non-Acute Systemic Toxicity | Under conditions of the<br>study, did not show acute<br>systemic toxicity in vivo. /<br>Pass | | |
| ISO 10993-10 | Irritation | Non-irritating | Under conditions of the<br>study, not an irritant. / Pass | | |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the<br>study, not a sensitizer. /<br>Pass | | |

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#### Clinical Performance Testing

Clinical testing is not needed for this device.

#### Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device, SafeSource Direct Blue Powder-Free Nitrile Exam Gloves, is as safe, as effective, and performs as well as or better than the legally marketed predicated device under K201390.