← Product Code [KGO](/productcode/KGO) · K253060

# Sterile Latex Powder Free Surgical Gloves (K253060)

_Protect Gloves Company Limited · KGO · May 22, 2026 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K253060

## Device Facts

- **Applicant:** Protect Gloves Company Limited
- **Product Code:** [KGO](/productcode/KGO.md)
- **Decision Date:** May 22, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4460
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Indications for Use

A Sterile Latex Powder Free Surgical Gloves is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

## Device Story

Sterile, disposable, powder-free natural rubber surgical gloves; intended for use by operating room personnel to protect surgical wounds from contamination. Device is worn on hands; provides physical barrier between clinician and patient. Manufactured in various sizes (5.5 to 9.0); sterilized via radiation (SAL 10^-6). Performance verified against ASTM D3577-19 standards for dimensions, physical properties (tensile strength, elongation), and barrier integrity. Used in clinical/surgical settings to maintain sterile field and prevent cross-contamination.

## Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing (ISO 10993-5, -10, -11, -23) and physical performance testing (ASTM D3577-19, D5151-19, D6124-06, D5712-15) demonstrate compliance with safety and performance standards.

## Technological Characteristics

Material: Natural rubber latex. Form factor: Sterile, powder-free surgical gloves in sizes 5.5-9.0. Sterilization: Radiation (SAL 10^-6). Standards: ASTM D3577-19 (specifications), ASTM D5151-19 (watertightness), ASTM D6124-06 (residual powder), ASTM D5712-15 (protein content). Biocompatibility: ISO 10993-5, 10, 11, 23. No software or electronic components.

## Regulatory Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

## Predicate Devices

- Sterile Latex Surgical Gloves powder free ([K212848](/device/K212848.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

May 22, 2026

Protect Gloves Company Limited
% Kiwi Xu
Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave
Shanghai, 200122
China

Re: K253060
Trade/Device Name: Sterile Latex Powder Free Surgical Gloves
Regulation Number: 21 CFR 878.4460
Regulation Name: Non-Powdered Surgeon's Glove
Regulatory Class: Class I, reserved
Product Code: KGO
Dated: April 22, 2026
Received: April 22, 2026

Dear Kiwi Xu:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K253060 - Kiwi Xu
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

{2}

K253060 - Kiwi Xu
Page 3

Sincerely,

ALLAN GUAN -S

For Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection
Control 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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF

|  DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.  |
| --- | --- |
|  510(k) Number (if known) K253060  |   |
|  Device Name Sterile Latex Powder Free Surgical gloves  |   |
|  Indications for Use (Describe) A Sterile Latex Powder Free Surgical Gloves is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.  |   |
|  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)  |   |
|  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."  |   |

{4}

Protect Gloves Company Limited
60/138 Moo.3 Mabyangporn Pluakdang Rayong 21140 ,Thailand.

# 510(K) Summary

K253060

(As requirement by 21 CFR 807.92)

Date prepared: May 20, 2026

## A. Applicant:

Name: Protect Gloves Company Limited
Address: 60/138 Moo.3 Mabyangporn Pluakdang Rayong 21140 ,Thailand.
Contact: Nathaphon Wachakorn
Title: Head of Firm Tel:
+6681 423 6868
Email: nathaphon@me.com

Submission Correspondent:
Primary contact: Ms. Kiwi Xu
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-58817802
Email: weijia.xu@sungoglobal.com
Secondary contact: Mr. Raymond Luo
Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-68828050

## B. Device:

Trade Name: Sterile Latex Powder Free Surgical Gloves
Model: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0

Regulatory Information
Classification Name: Surgeon’s Gloves
Classification: Class I
Product code: KGO
Regulation Number: 21 CFR 878.4460
Review Panel: General & Plastic Surgery

## C. Predicate device:

K212848
Applicant: Pentavest Holdings Sdn Bhd
Device Name: Sterile Latex Surgical Gloves powder free

K253060

{5}

Protect Gloves Company Limited
60/138 Moo.3 Mabyangporn Pluakdang Rayong 21140 ,Thailand.

Regulatory Information
Classification Name: Surgeon’s Gloves
Classification: Class I
Product code: KGO
Regulation Number: 21 CFR 878.4460
Review Panel: General & Plastic Surgery

## D. Indications for use of the device:
A Sterile Latex Powder Free Surgical Gloves is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

## E. Device Description
Sterile Latex Powder Free Surgical Gloves are sterile, disposable, and powder-free. The gloves are made of natural rubber. The glove is designed to meet the specification of ASTM D3577-19 Standard Specification for Rubber Surgical Gloves. The glove has a shelf life of 3 years, is white in color and comes in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0.

## F. Summary of Technological Characteristics
Table 1 General Comparison of Proposed and Predicate Devices

|  Device | Proposed Device | Predicate Device | Result  |
| --- | --- | --- | --- |
|  510K # | K253060 | K212848 | -  |
|  Manufacturer | Protect Gloves Company Limited | Pentavest Holdings Sdn Bhd | -  |
|  Product Name | Sterile Latex Powder Free Surgical Gloves | Sterile Latex Surgical Gloves Powder Free | Similar  |
|  Product Code | KGO | KGO | Same  |
|  Regulation Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same  |
|  Indications for use | A Sterile Latex Powder Free Surgical Gloves is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. | Same  |
|  Powder/Powder free | Powder free | Powder free | Same  |
|  Material | Natural rubber | Natural rubber | Same  |
|  Classification as per ASTM D3577-19, Standard Specification for Rubber Surgical Gloves | Type I-gloves compounded primary from natural rubber latex | Type I-gloves compounded primary from natural rubber latex | Same  |
|  Size | 5.5 6.0 6.5 | 6.0 6.5 7.0 7.5 | Similar  |

K253060

{6}

Protect Gloves Company Limited
60/138 Moo.3 Mabyangporn Pluakdang Rayong 21140 ,Thailand.

|  Device | Proposed Device | Predicate Device | Result  |
| --- | --- | --- | --- |
|   | 7.0 | 8.0 |   |
|   | 7.5 | 8.5 |   |
|   | 8.0 | 9.0 |   |
|   | 8.5 |  |   |
|   | 9.0 |  |   |
|  Sterilization | Radiation SAL-10^{-6} | Radiation SAL-10^{-6} | Same  |
|  Use | Singe use | Single use | Same  |
|  Label and Labeling | Meet FDA’s label requirements | Meet FDA’s label requirements | Same  |
|  Type of use | OTC | OTC | Same  |
|  Shelf-life | Three years | Three years | Same  |

Table 2 Technical Comparison of Proposed and Predicate Devices

|  Characteristic | Subject device | Predicate device K212848 | Comparison  |
| --- | --- | --- | --- |
|  Dimensions | 5.5: 288-292 mm |  | Different  |
|  Length: | 6.0: 276-280 mm |  |   |
|  5.5(Min 245mm) | 6.5: 278-280 mm | 380mm |   |
|  6.0-9.0 (Min 265mm) | 7.0: 280-286 mm |  |   |
|   | 7.5: 279-285 mm |  |   |
|   | 8.0: 280-285 mm |  |   |
|   | 8.5: 280-282 mm |  |   |
|   | 9.0: 289-290 mm |  |   |
|  Width |  |  | Similar  |
|  5.5(70±6mm) | 5.5: 73-75mm | 74 mm |   |
|  6.0(76±6mm) | 6.0: 79-80 mm | 86 mm |   |
|  6.5 (83±6mm) | 6.5: 84-85mm | 92 mm |   |
|  7.0 (89±6mm) | 7.0: 89-91 mm | 98 mm |   |
|  7.5 (95±6mm) | 7.5: 95-97 mm | 105 mm |   |
|  8.0 (102±6mm) | 8.0: 100-101 mm | 110 mm |   |
|  8.5 (108±6mm) | 8.5: 109-110 mm | 116 mm |   |
|  9.0 (114±6mm) | 9.0: 114-115 mm |  |   |
|  Cuff, Palm, Finger Tip Min 0.10mm | Cuff: 0.13-0.18mm | Cuff: 0.12 mm | Similar  |
|   |  Palm:0.15-0.19mm | Palm:0.16 mm |   |
|   |  Finger: 0.17-0.20mm | Finger: 0.21 mm |   |
|  Tensile Strength 24Mpa minimum (Before aging) | 26.22-33.06MPa | 28.55 MPa | Similar  |
|  Ultimate Elongation 750% minimum (Before aging) | 809.45-888.74% | 870 % | Similar  |

K253060

{7}

Protect Gloves Company Limited
60/138 Moo.3 Mabyangporn Pluakdang Rayong 21140 ,Thailand.

|  Characteristic | Subject device | Predicate device K212848 | Comparison  |
| --- | --- | --- | --- |
|  Stress at 500% 5.5 Mpa Max (Before aging) | 4.14-5.04MPa | 5.1MPa | Similar  |
|  Tensile Strength 18Mpa minimum (after aging) | 23.23-28.36 MPa | 23.48 MPa | Similar  |
|  Ultimate Elongation 560% minimum (after aging) | 809.97-888.06% | 731% | Similar  |
|  Freedom from holes AQL 1.5 | AQL 1.5 | AQL 1.0 | Different Meets ASTM D3577-2019 and ASTM D5151-2019, Standard Test Method for Detection of Holes in Medical Gloves  |
|  Powder residue for powder free glove powder content <2mg/glove | 0.68-0.70 mg/glove | 0.40 mg/glove | Different  |
|  Aqueous Extractable Protein Content ≤200ug/dm² | 163.65-184.24 ug/dm² | 50 ug/dm² | Different  |
|  Skin Irritation & Skin Sensitization | Non-irritant and non-sensitizing | Non-irritant and non sensitizer | Same  |
|  In-vitro cytotoxicity | Cytotoxic | Cytotoxic | Same  |
|  Acute Systemic toxicity | Under the conditions of study, the device extracts do not pose an acute systemic toxicity concern. | Under the conditions of study, the device extracts do not pose an acute systemic toxicity concern. | Same  |
|  Bacterial Endotoxin | <20EU/pair of gloves | <20EU/pair of gloves | Same  |

## Analysis:

The length and powder residue of the gloves are slightly different from those of the predicate device. But the proposed gloves have been tested according to ASTM D3577-19 (2023) for dimensions and ASTM D6124-06 (2022) for powder residue respectively, and both dimensions and powder residue met the requirements of ASTM D 3577-19. The protein content of the proposed device is larger than that of the predicate device. However, the proposed device doesn't have special label claim of 50 ug/dm² or less per glove of extractable protein and has been conducted the testing of aqueous extractable protein content according to ASTM D3577 and met its requirement.

In addition, the proposed device use different AQL of water tightness test to the predicate device, but the AQL 1.5 is complied with the ASTM D 3577-19 and ASTM D5151-19, and can demonstrate the effectiveness of the proposed device.

K253060

{8}

Protect Gloves Company Limited
60/138 Moo.3 Mabyangporn Pluakdang Rayong 21140 ,Thailand.

Thus, such differences won't raise any concerns of safety and effectiveness of the proposed device.

## G. Summary of Non-Clinical Testing

### Biocompatibility

Biocompatibility Testing according to ISO 10993-1:2018, the nature of body contact for the subject device is external communicating device: tissue/bone/dentin and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to evaluate the biocompatibility of Sterile Latex Powder free Surgical gloves:

- ISO 10993-05:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In VitroCytotoxicity
- ISO 10993-10:2021 Biological Evaluation of Medical Devices - Part 10: Tests for Skin Sensitization
- ISO 10993-23:2021 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation
- ISO 10993-11:2017 Biological evaluation of medical device – Part 11: Tests for systemic toxicity

### Performance Testing

Physical performance testing of the proposed device were conducted as per ASTM D3577-19 Standard Specification for Rubber Surgical Gloves. Extractable Protein Test was conducted to for the determination of protein levels in the gloves according to ASTM D3577 Standard Test Method for Analysis of Aqueous Extractable Protein in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method.

To summarize, the performance testing of the subject device were conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:

- ASTM D3577-19 Standard Specification for Rubber Surgical Gloves.
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 (Reapproved 2022) Standard Test Method for Residual Powder on Medical Gloves
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM D3078-02 (2013) Standard Test Method for Determination of Leakage in Flexible Packaging by Bubble Emission Method
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM D7160-16 Determination of Expiration Date for Medical Gloves

Performance testing and biocompatibility testing are summarized in below table 3.

Table 3: Summary of Performance Testing &amp; Biocompatibility Testing

|  Test Methodology | Purpose | Acceptance Criteria | Result  |
| --- | --- | --- | --- |
|  Dimension ASTM D3577-19 | To determine the length of the gloves | Length: 5.5(Min 245mm) 6.0-9.0 (Min 265mm) | Pass 5.5: 288-292 mm 6.0: 276-280 mm 6.5: 278-280 mm 7.0: 280-286 mm 7.5: 279-285 mm  |

K253060

{9}

Protect Gloves Company Limited
60/138 Moo.3 Mabyangporn Pluakdang Rayong 21140 ,Thailand.

|  Test Methodology | Purpose | Acceptance Criteria | Result  |
| --- | --- | --- | --- |
|   |  |  | 8.0: 280-285 mm 8.5: 280-282 mm 9.0: 289-290 mm  |
|   |  To determine the width of the gloves | 5.5(70±6mm) 6.0(76±6mm) 6.5 (83±6mm) 7.0 (89±6mm) 7.5 (95±6mm) 8.0 (102±6mm) 8.5 (108±6mm) 9.0 (114±6mm) | Pass 5.5: 73-75mm 6.0: 79-80 mm 6.5: 84-85mm 7.0: 89-91 mm 7.5: 95-97 mm 8.0: 100-101 mm 8.5: 109-110 mm 9.0: 114-115 mm  |
|   |  To determine the thickness of the gloves | Palm:0.10min Finger: 0.10 min Cuff: 0.10 min | Pass Cuff: 0.13-0.18mm Palm:0.15-0.19mm Finger: 0.17-0.20mm  |
|  Physical Properties ASTM D3577-19 | To determine the physical property of tensile strength of the gloves | **Before Aging** Tensile strength 24Mpa min for all sizes **After Aging** Tensile strength 18Mpa min for all sizes | Pass **Before Aging** 26.22-33.06MPa for all sizes **After Aging** 23.23-28.36 MPa for all sizes  |
|   |  To determine the physical property of ultimate elongation of the gloves | **Before Aging** 750% min for all sizes **After Aging** 560% min for all sizes | Pass **Before Aging** 809.45-888.74% for all sizes **After Aging** 809.97-888.06% for all sizes  |
|   |  To determine the physical properties of stress at 500% elongation of the gloves | **Before Aging** 5.5Mpa, max for all sizes | Pass **Before Aging** 3.07-3.98MPa  |
|  Watertight Test ASTM D5151-19 | To determine the watertightness of the gloves | AQL 1.5 | Pass No glove appears leakage for the size of 750 gloves have been tested.  |
|  Residual power ASTM D6124-06 | To determine the residual power in the gloves. | 2mg per glove or less | Pass 0.68-0.70 mg/glove for all tested gloves  |
|  Aqueous soluble protein content ASTM D5712-15 | To determine the aqueous soluble protein content in the gloves | 200 μ g/dm² max for all sizes. | Pass 163.65-184.24 ug/dm² for all tested gloves.  |

K253060

{10}

Protect Gloves Company Limited
60/138 Moo.3 Mabyangporn Pluakdang Rayong 21140 ,Thailand.

|  Test Methodology | Purpose | Acceptance Criteria | Result  |
| --- | --- | --- | --- |
|  Irritation ISO 10993-23:2021 | To evaluate the potential skin irritation caused by test article contact with the skin surface of rabbits. | Negligibly irritating | Pass Under the condition of this study, the device is negligibly irritating.  |
|  Sensitization ISO 10993-10:2021 | The test was designed to evaluate the potential of a test article to cause skin sensitization. | Non-sensitizing | Pass Under the conditions of the study, the device is non-sensitizing  |
|  Acute Systemic toxicity ISO 10993-11 | The test article was evaluated to determine whether leachables extracted from the test article would cause acute systemic toxicity following injection into mice. | Non-acute systemic toxicity | Pass Under the conditions of the study, there is no mortality or evidence of acute systemic toxicity from the extracts.  |
|  Material Mediated Pyrogenicity USP <151> | To determine whether the device elicits a febrile reaction. | Not pyrogenic | Pass Under the conditions of the study, not pyrogenic.  |
|  Bacterial Endotoxin USP 43 <161> | To determine the bacterial endotoxin of each sample meet the requirement of endotoxin limit. | <20EU/pair of gloves | Pass Under the conditions of the test, the bacterial endotoxin of each test article was less than 20 EU/pair.  |
|  Shelf life ASTM D7160-16 (2023) | To validate the shelf life of the proposed device. | Three years | Pass  |

## H. Clinical Test Conclusion

No clinical study is included in this submission.

## I. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Sterile Latex Powder Free Surgical Glove is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K212848.

K253060

---

**Source:** [https://fda.innolitics.com/device/K253060](https://fda.innolitics.com/device/K253060)

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