REXLON is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
REXSIL is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Device Description

REXLON is a sterilized nonabsorbable monofilament surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXLON suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. REXLON sutures are not coated. The sutures are dyed black (Logwood) or blue (FD&C Blue No.2) to enhance visibility in tissue. The suture is also available undyed (Natural).
REXLON suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture.

REXSIL is a sterilized nonabsorbable silk surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXSIL suture is a nonabsorbable, sterile, surgical suture composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. REXSIL sutures are processed to remove the natural waxes and gums. REXSIL suture is dyed black (Logwood) and coated with silicone. REXSIL suture is also available undyed (Natural).
REXSIL suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surqical suture.

AI/ML Overview

The provided text describes acceptance criteria and the results of a study to demonstrate substantial equivalence for two medical devices: REXLON (nonabsorbable polyamide surgical suture) and REXSIL (nonabsorbable silk surgical suture). Both devices are sutures and their acceptance criteria are based on established USP (United States Pharmacopoeia) and ISO (International Organization for Standardization) standards.

Here's a breakdown of the requested information, focusing on the REXLON and REXSIL devices as described:

REXLON (Nylon Monofilament Suture)

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Reported Device Performance (REXLON)
USP 35 <861> SUTURES - DIAMETER	Complies with the diameter requirement
USP 35 <871> SUTURES - NEEDLE ATTACHMENT	Meets the requirements defined
USP 35 <881> TENSILE STRENGTH	Complies with the tensile requirement
USP Nonabsorbable Surgical Suture	Conforms to USP requirements
ASTM F88-09 (Seal Strength)	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
ASTM F1929-98(2004) (Seal Leaks)	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
USP <71> STERILITY TEST	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
USP 36, <151>; Pyrogen Test	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
ISO 11135-1:2007 (Ethylene Oxide Sterilization)	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
USP <85> Bacterial Endotoxin Limit	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
ISO 10993 (Biological Evaluation)	Biocompatible per ISO 10993-1, and other parts of ISO 10993 evaluation completed.
Shelf life stability (Real-time and accelerated aging)	Stable over the proposed shelf life

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each individual test conducted (e.g., how many sutures were measured for diameter or tensile strength). It only states that "REXLON were evaluated in accordance with the listed tests above." The data provenance is non-clinical, laboratory testing rather than human subject data. There is no information regarding country of origin for the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert interpretation of results, but rather laboratory testing against established physical and chemical standards.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as this involves objective measurements against established standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a non-clinical evaluation of surgical sutures, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a non-clinical evaluation of surgical sutures, not an algorithm.

7. The type of ground truth used

The ground truth used for REXLON (and REXSIL) is based on established industry standards and pharmacopoeia monographs, specifically:

United States Pharmacopoeia (USP) requirements for nonabsorbable surgical sutures (e.g., diameter, tensile strength, needle attachment).
ASTM (American Society for Testing and Materials) standards for seal strength and leak detection.
ISO (International Organization for Standardization) standards for sterilization and biological evaluation.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

9. How the ground truth for the training set was established

Not applicable.

REXSIL (Nonabsorbable Silk Suture)

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Reported Device Performance (REXSIL)
USP 35 <861> SUTURES - DIAMETER	Complies with the diameter requirement
USP 35 <871> SUTURES - NEEDLE ATTACHMENT	Meets the requirements defined
USP 35 <881> TENSILE STRENGTH	Complies with the tensile requirement
USP Nonabsorbable Surgical Suture	Conforms to USP requirements
ASTM F88-09 (Seal Strength)	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
ASTM F1929-98 (Seal Leaks)	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
USP <71> STERILITY TEST	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
USP <151>; Pyrogen Test	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
ISO 11135-1:2007 (Ethylene Oxide Sterilization)	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
USP <85> Bacterial Endotoxin Limit	Not explicitly stated "complies," but implies acceptable performance as part of overall non-clinical testing.
ISO 10993 (Biological Evaluation)	Biocompatible per ISO 10993-1, and other parts of ISO 10993 evaluation completed.
Shelf life stability (Real-time and accelerated aging)	Stable over the proposed shelf life

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes for each individual test conducted. It only states that "REXSIL were evaluated in accordance with the listed tests above." The data provenance is non-clinical, laboratory testing. No information on country of origin for the data is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study requiring expert interpretation of results, but rather laboratory testing against established physical and chemical standards.

4. Adjudication method for the test set

Not applicable. No adjudication method is mentioned as this involves objective measurements against established standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a non-clinical evaluation of surgical sutures, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a non-clinical evaluation of surgical sutures, not an algorithm.

7. The type of ground truth used

The ground truth used for REXSIL is based on established industry standards and pharmacopoeia monographs, specifically:

United States Pharmacopoeia (USP) requirements for nonabsorbable surgical sutures (e.g., diameter, tensile strength, needle attachment).
ASTM (American Society for Testing and Materials) standards for seal strength and leak detection.
ISO (International Organization for Standardization) standards for sterilization and biological evaluation.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-driven device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 2, 2017

SM ENG CO., Ltd % Mr. Sanglok Lee Wise Company, Inc. #306, 3 Daerim-ro 27ga-gil Yeongdeungpo-gu, 07413 KR

Re: K161633

Trade/Device Name: REXLON®, REXSIL® Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: Class II Product Code: GAR, GAP Dated: January 24, 2017 Received: January 31, 2017

Dear Mr. Lee:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K161633

Device Name

REXLON

Indications for Use (Describe)

REXLON' is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

{3}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the nollection of informating data sources, gather and needed and complete 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}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161633

Device Name

REXSIL

Indications for Use (Describe)

REXSIL is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

{5}------------------------------------------------

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 institutions, search existing data sources, gather and maintain the data needed and complete and reviouslion 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."

{6}------------------------------------------------

510(k) Summary

The assigned 510(k) Number: K161633

Date of Submission: January 24, 2017

Applicant

Company name: SM ENG CO., LTD Address: 46, Nakdong-daero 1302beon-gil, Sasang-gu, Busan, Korea TEL: +82 51 305 8016 FAX: +82 51 305 8021 Email: leesg@sm-eng.net

Submission Correspondent

Sanglok, Lee Wise COMPANY Inc. #1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org

Subject Device Information

1. Nylon Monofilament Suture With or Without Needle

1.1 Proposed Device Identification

Proprietary Name: REXLON Common Name: Nonabsorbable Polyamide Suture With or Without Needle Device Class: Class II Regulation Number: 21 C.F.R. 878.5020 Product Code: GAR Device Classification Name: Suture, Nonabsorbable, Synthetic, Polyamide

1.2 Indication for use

REXLON is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

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1.3 Predicate devices

Predicate device 01 510(k) Number: K080684 Device Name: WG-Surgical Sutures with Needle Classification Name: Suture, Nonabsorbable, Synthetic, Polyamide Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD.

Predicate device 02 510(k) Number: K982646 Device Name: Reli Classification Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE Manufacturer: AILEE CO LTD.

1.4 Device Description

REXLON suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. REXLON sutures are not coated. The sutures are dyed black (Logwood) or blue (FD&C Blue No.2) to enhance visibility in tissue. The suture is also available undyed (Natural).

REXLON suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. Available suture size is as below.

Dyed suture Black (Logwood): USP 11-0 ~ USP 1
i Dyed suture Blue (FD&C Blue No.2): USP 8-0 ~ USP 2
Undyed suture (Natural): USP 8-0 ~ USP 1

1.5 Non-Clinical Test Conclusion

USP 35 <861> SUTURES - DIAMETER

USP 35 <871> SUTURES - NEEDLE ATTACHMENT

USP 35 <881> TENSILE STRENGTH

USP Nonabsorbable Surgical Suture

ASTM F88-09. Standard Test Method for Seal Strength of Flexible Barrier Materials;

ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration

USP <71> STERILITY TEST

USP 36, <151>; Pyrogen Test

ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide-Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices:

USP <85> Bacterial Endotoxin Limit;

ISO 10993, Biological Evaluation of Medical Devices: Including:

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

REXLON were evaluated in accordance with the listed tests above.

Real-time and accelerated aging stability testing was performed to support shelf life of REXLON. Testing confirmed that the sutures conform to USP requirements for nonabsorbable sutures, are biocompatible per ISO 10993-1, and are stable over the proposed shelf life

1.6 Substantially Equivalent Conclusion

	Table 1: Substantial Equivalence Comparison

Property	Proposed deviceREXLON	Predicate device 01WG-Surgical Sutureswith Needle	Predicate device 02Reli
510(k) Number	K161633	K080684	K982646
Product Code	GAR	GAR	GAR
Regulation No,	21 C.F.R. 878.5020	21 C.F.R. 878.5020	21 C.F.R. 878.5020
Class	II	II	II
Sterile	Yes	Yes	Yes
Single Use	Yes	Yes	Yes
Intended use	Indication for use is ingeneral soft tissueapproximation and/orligation, including use inophthalmic procedures,	Indication for use is ingeneral soft tissueapproximation and/orligation, including use inophthalmic procedures.	Indication for use as nonabsorbable sutures is ingeneral soft tissueapproximation and/orligation, including use in
	but not for use incardiovascular or neuraltissue.		cardiovascular,ophthalmic, neuraltissue.
Configuration	NonabsorbablePolyamide Suture WithNeedle	NonabsorbablePolyamide Suture WithNeedle	NonabsorbablePolyamide Suture WithNeedle
		Suture
Raw Suture Material	polyamide surgicalsuture from long-chainaliphatic polymers Nylon6 and Nylon 6,6	polyamide surgicalsuture from long-chainaliphatic polymers Nylon6 and Nylon 6,6	polyamide surgicalsuture from long-chainaliphatic polymers Nylon6 and Nylon 6,6
Suture Manufacturer	Ashaway Line & TwineMfg. Co.	Pearsalls Limited	Ashaway Line & TwineMfg. Co.
Color (Colorant)	Dyed suture Black(Logwood), Blue(FD&C Blue No.2) andUndyed suture (Natural)	Dyed suture Black(Logwood), Blue &phthalocyanine blue(FD&C Blue No.2) andUndyed suture (Natural)	Dyed suture Black(Logwood), Blue(FD&C Blue No.2) andUndyed suture (Natural)
Coating material	Not used	Not used	Not used
Absorbable/Nonabsorbable	Nonabsorbable	Nonabsorbable	Nonabsorbable
Braided/Monofilament	Monofilament	Monofilament	Monofilament
Suture Size	Available suture sizesare standard accordingto USP requirementsAvailable suture size isas below.#1 Dyed suture Black(Logwood): USP 11-0~~USP 1#2 Dyed suture Blue(FD&C Blue No.2): USP8-0~~USP 2#3 Undyed suture(Natural): USP 8-0~USP1	Available suture sizesare standard accordingto USP requirements	Available suture sizesare standard accordingto USP requirements

Length of Suture	15cm, 20cm, 30cm,35cm, 40cm, 45cm,50cm 60cm, 70cm,75cm, 80cm, 100cm,150cm, 200cm	Unknown	15cm, 20cm, 30cm,45cm, 50cm
Diameter of Suture	The suture diameters ofproposed device complywith the diameterrequirement listed inU5P 35 <861> Diameter.	The suture diameters ofproposed device complywith the diameterrequirement listed inU5P 35 <861> Diameter.	Meet the requirementsdefined in the USP
Tensile strength	The tensile strengths ofproposed device complywith the tensilerequirement listed inU5P 35 <881> TensileStrength	The tensile strengths ofproposed device complywith the tensilerequirement listed inU5P 35 <881> TensileStrength	Meet the requirementsdefined in the USP
Needle Attachment	The bond betweensuture and needle of theapplicant device meetthe requirements definedin USP 35 <871>.	The bond betweensuture and needle of theapplicant device meetthe requirements definedin USP 35 <871>.	Meet the requirementsdefined in the USP
Needle
Material	Stainless Steel	Stainless Steel	Stainless Steel
Needle type	Reverse Cutting, Taperpoint, Spatula	Taper, cutting, spatual,blund ,taper cut,diamond, premimumcutting and square	Spatula, taper point,Blunt point

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The proposed device, REXLON, is determined to be Substantially Equivalent (SE) to the predicate device, WG-Surgical Sutures with Needle (K080684) and Reli (K982646) in respect of safety and effectiveness.

{11}------------------------------------------------

2. Nonabsorbable Silk Suture With or Without Needle

2.1 Proposed Device Identification

Proprietary Name: REXSIL Common Name: Nonabsorbable Braided Silk Suture With or Without Needle Device Class: Class II Regulation Number: 21 C.F.R. 878.5030 Product Code: GAP Device Classification Name: Suture, Nonabsorbable, Silk

2.2 Indication for use

REXSIL is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

2.3 Predicate devices

Predicate device 01 510(k) Number: K080684 Device Name: WG-Surgical Sutures with Needle Classification Name: SUTURE, NONABSORBABLE, SILK Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD

Predicate device 02 510(k) Number: K982646 Device Name: Reli Classification Name: SUTURE, NONABSORBABLE, SILK Manufacturer: AILEE CO LTD.

2.4 Device Description

REXSIL is a sterilized nonabsorbable silk surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.

REXSIL suture is a nonabsorbable, sterile, surgical suture composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. REXSIL sutures are processed to remove the natural waxes and gums. REXSIL suture is dyed black (Logwood) and coated with silicone. REXSIL suture is also available undyed (Natural).

REXSIL suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surqical suture. Available suture size is as below.

Dyed suture Black (Logwood): USP 8-0 ~ USP 2
Undyed suture (Natural): USP 7-0 ~ USP 2

2.5 Non-Clinical Test Conclusion

USP 35 <861> SUTURES - DIAMETER USP 35 <871> SUTURES - NEEDLE ATTACHMENT USP 35 <881> TENSILE STRENGTH USP Nonabsorbable Surgical Suture ASTM F88-09. Standard Test Method for Seal Strength of Flexible Barrier Materials; ASTM F1929-98-98 Standard Test Method for Detecting Seal Leaks in Porous Medical

{12}------------------------------------------------

Package by Dye Penetration

USP <71> STERILITY TEST

USP <151>; Pyrogen Test

ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices;

USP <85> Bacterial Endotoxin Limit;

ISO 10993, Biological Evaluation of Medical Devices:

Includina: