Safe Secure Sterilization Pouches and Rolls are intended to be used to enclose another medical device, in a single or double pouch configuration, that is to be sterilized by a health care provider using:

· Gravity steam at 121°C (250°F) for 30 minutes: 25 minutes dry time
· Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
· Pre-vacuum steam at 134°C (273°F) for 3 minutes: 20 minutes dry time
· Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
· Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60oC (140oF).
· The recommended hydrogen peroxide vapor sterilization cycle is the STERRAD® 100S Short Cycle.
The steam and EO device is not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen. The hydrogen peroxide device has been validated for devices that contain a lumen; the 100S has been validated for medical devices with a single stainless steel lumen with an inside diameter of ≥1mm and an length of ≤125mm as well as lumens with an inside diameter ≥2mm and a length of ≤250mm only.
The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam. EO, or hydrogen peroxide sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam, from yellow to brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide.
The Tyvek version of the pouch is for EO and hydrogen peroxide sterilization only.
If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization (for paper pouch), two years after hydrogen peroxide sterilization and five years for EO sterilization (for Tyvek Pouch). The maximum validated pouch load is 2.64 pounds (1.2kg).

Device Description

Tyvek Sterilization Pouches with Chevron Seal are constructed Tyvek backing of fine, continuous, high-density polyethylene fibers, with front material consisting of a clear, laminated polyethylene terephthalate / low density polyethylene (LDPE) or LDPE-ethylene- vinylacetate copolymer film.
The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed.
The self-seal pouch permits sealing of the pouch without heat-sealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle.
Chemical Indicators, are placed on the outside of the sterilization pouches indicate sterilant exposure, and a way to differentiate pouches that have been processed in sterilization cycles from unprocessed units.
The color of the Indicators (3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248) changes from blue to pink after exposer to hydrogen peroxide sterilization. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least five years.

AI/ML Overview

The document outlines the K180139 510(k) premarket notification for "Safe Secure Sterilization Pouches and Rolls." While it details numerous tests and states "Pass" for results, it does not provide specific acceptance criteria or quantitative performance data for each test. Therefore, a table of acceptance criteria and reported device performance cannot be fully constructed with numerical values from the provided text.

Based on the information provided, here's a breakdown of the requested elements:

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

The document lists various tests but does not explicitly state the numerical acceptance criteria or the quantitative reported performance for most of them. It generally indicates that the device "Pass"ed the tests and "meet acceptable criteria" or "meet ISO and ASTM requirements."

Test Name	Acceptance Criteria (as implied)	Reported Device Performance (as implied)
Package Integrity
Seal Strength Test	Meet ASTM F88/F88M-15 requirements	Pass
Seal Leak Test	Meet ASTM F1929-15 requirements	Pass
Sterilization Chemical Indicator Test and Visual Inspection	Visual examination to confirm proper color change after exposure to sterilant.	Pass (Chemical indicators change color as expected for steam, EO, and hydrogen peroxide: green to purple for steam, yellow to brown for EO, blue to pink for hydrogen peroxide).
Material Compatibility	Demonstrate material compatibility characteristics of Tyvek Sterilization Pouches through seal strength, microbial barrier, burst, and peel open tests.	Pass
Biocompatibility	Materials are non-toxic, biological evaluations meet acceptable criteria, provides reasonable assurance for safety (referenced ISO 10993-1 and ISO 10993-5).	Pass (Both subject and predicate devices were non-cytotoxic post-sterilization).
Shelf Life	Physical properties and microbial barrier of processed Tyvek Pouches maintained at end of shelf life.	Pass (Validated for 2 years before sterilization; maintains sterility for 6 months after steam, 2 years after hydrogen peroxide, 5 years after EO (Tyvek Pouch), 24 months after EO (paper pouch)).
Sterilization Validation	Validate sterilization cycle using full, half, and partial/fail cycles (referenced ISO 11140-1, ISO 11138, ISO 14161).	Pass
Chemical Indicator	Demonstrate compliance to "Submissions for Chemical Indicators - Guidance for Industry and FDA Staff" (as applicable under K170321).	Pass

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for the test set for any of the non-clinical tests.

Data Provenance: The submission sponsor is "Safe Secure Packing (Shenzhen) Co., Ltd" located in Guangdong Province, China. This suggests the testing data likely originates from China. The document does not specify if the studies were retrospective or prospective, but non-clinical performance and validation tests are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device and study. The document describes non-clinical performance testing of a sterilization pouch, not a diagnostic or AI-based medical device that would require expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to this type of device and study. Adjudication methods are typically used in clinical studies involving interpretation of medical images or data by multiple experts, which is not the case here.

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

This information is not applicable to this type of device and study. An MRMC study is relevant for AI-powered diagnostic devices involving human readers, which this sterilization pouch is not.

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

This information is not applicable to this type of device and study. A standalone algorithm performance study is relevant for AI-powered diagnostic devices, which this sterilization pouch is not.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable/relevant in the typical sense for this device. The "ground truth" for the non-clinical tests would be the established scientific principles and standards for sterility, package integrity, and material biocompatibility. For example, for sterilization validation, the ground truth is the successful inactivation of microbes to a specified sterility assurance level (SAL). For chemical indicators, the ground truth is the expected color change upon exposure to the sterilant under specified conditions.

8. The sample size for the training set

This information is not applicable to this type of device. There is no AI or machine learning algorithm involved that would require a training set.

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

This information is not applicable to this type of device, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

January 3, 2019

Safe Secure Packing Co., Ltd. Howard Jia, President Yaoshan Industrial Park Xiegang Town, Dongguan City, CN 523601

Re: K180139

Trade/Device Name: Safe Secure Sterilization Pouches and Rolls Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG Dated: November 27, 2018 Received: November 28, 2018

Dear Howard Jia:

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/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's 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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Elizabeth F. Claverie -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180139

Device Name

Safe Secure Sterilization Pouches and Rolls

Indications for Use (Describe)

· Gravity steam at 121°C (250°F) for 30 minutes: 25 minutes dry time
· Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes dry time
· Pre-vacuum steam at 134°C (273°F) for 3 minutes: 20 minutes dry time
· Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time

· Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60oC (140oF).

· The recommended hydrogen peroxide vapor sterilization cycle is the STERRAD® 100S Short Cycle.
The steam and EO device is not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen. The hydrogen peroxide device has been validated for devices that contain a lumen; the 100S has been validated for medical devices with a single stainless steel lumen with an inside diameter of ≥1mm and an length of ≤125mm as well as lumens with an inside diameter ≥2mm and a length of ≤250mm only.

The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam. EO, or hydrogen peroxide sterilization process and to distinguish between processed devices. The chemical indicators change from green to purple after exposure to steam, from yellow to brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide.

The Tyvek version of the pouch is for EO and hydrogen peroxide sterilization only.

If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization (for paper pouch), two years after hydrogen peroxide sterilization and five years for EO sterilization (for Tyvek Pouch). The maximum validated pouch load is 2.64 pounds (1.2kg).

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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Pouch Material	Sterilization Method	Size	ModelNumber
Medical GradePaper	Steam or EO Sterilization Pouch/RollProducts	L: 2 – 30"W: 2 – 30"	ABHSP1TABABSSP1TAB
Tyvek	EO Sterilization Pouch/Roll Products	W: 2 – 30"	ABSST1TABABHST1TAB
Tyvek	Hydrogen Peroxide SterilizationPouch/Roll Products	L: 2 – 30"W: 2 – 30"	ABSST2TABABHST2TAB

The maximum validated pouch load is 2.64 pounds (1.2kg).

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K180139

510(k) Summary

Submission Sponsor

Safe Secure Packing (Shenzhen) Co., Ltd Yaoshan Industrial Park, Xiegang Town, Dongguan City, Guangdong Province, 523601 China.

Date Prepared

November 27, 2018

Device Identification

Trade/Proprietary Name: Safe Secure Sterilization Pouches and Rolls Common/Usual Name: Sterilization Pouch Classification Name: Sterilization Wrap Classification Regulation: 21 CFR Part 880.6850 Product Code: FRG Device Class: 2 Classification Panel: General and Plastic Surgery

Predicate Device

K153540 - Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators

Device Description

The pouches are used to enclose medical devices that are to be sterilized by a healthcare provider following manufacturer's instructions, devices are inserted into Tyvek Sterilization Pouches and sealed.

The self-seal pouch permits sealing of the pouch without heat-sealing equipment, whereas the heat-sealable pouches must be heat sealed prior to the cycle.

Chemical Indicators, are placed on the outside of the sterilization pouches indicate sterilant exposure, and a way to differentiate pouches that have been processed in sterilization cycles from unprocessed units.

The color of the Indicators (3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248) changes from blue to pink after exposer to hydrogen peroxide sterilization. After completion of the sterilization process, the pouches maintain sterility of the enclosed medical devices for at least five years.

Indications for Use

. Gravity steam at 121°C (250°F) for 30 minutes; 25 minutes dry time
. Pre-vacuum steam at 132°C (270°F) for 4 minutes; 20 minutes drytime
. Pre-vacuum steam at 134°C (273°F) for 3 minutes; 20 minutes dry time
. Pre-vacuum steam at 135°C (275°F) for 3 minutes; 16 minutes dry time
Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% relative humidity for 60 . minutes. Aeration time of 8 hours at 60oC (140°F).
The recommended hydrogen peroxide vapor sterilization cycle is the STERRAD® 100S Short Cycle. .

The steam and EO device is not intended and has not been validated for sterilization of devices that contain lumens. The hydrogen peroxide device has been validated for devices that contain a lumen; the 100S has been validated for medical devices with a single stainless steel lumen with an inside diameter of ≥1mm and an length of ≤125mm as well as lumens with an inside diameter ≥2mm and a length of ≤250mm only.

Howard Jia, President Tel: 86-755-27040498 Fax: 86-755-27040488 howard.jia@anbaopack.com

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The external chemical indicators on the pouches/rolls are intended to demonstrate that the device has been exposed to the steam, EO, or hydrogen peroxide sterilization process and to distinguish between processed and unprocessed devices. The chemical indicators change from green to purple after exposure to steam, from yellow to brown after exposure to ethylene oxide, and from blue to pink for hydrogen peroxide.

The Tyvek version of the pouch is for EO and hydrogen peroxide sterilization only.

If stored according to the recommended conditions, the products before sterilization have a maximum shelf life of 2 years from the date of manufacture. The pouches are intended to allow sterilization of the enclosed medical device(s) and also to maintain sterility (SAL=10-6). The subject device is intended and has been validated to maintain sterility of the enclosed devices for 6 months after steam sterilization, 24 months after EO sterilization (for paper pouch), two years after hydrogen peroxide sterilization and five years for EO sterilization (for Tyvek Pouch).

The maximum validated pouch load is 2.64 pounds (1.2kg).

Pouch Material	Sterilization Method	Size	Model Number
Medical Grade Paper	Steam or EO Sterilization Pouch/Roll Products	L: 2 - 30"W: 2 - 30"	ABHSP1TABABSSP1TAB
Tyvek	EO Sterilization Pouch/Roll Products	W: 2 - 30"	ABSST1TABABHST1TAB
Tyvek	Hydrogen Peroxide Sterilization Pouch/Roll Products	L: 2 - 30"W: 2 - 30"	ABSST2TABABHST2TAB

Technological Characteristics Comparison Table

The subject device has the same intended use of the device as its predicate and the same technological characteristics.

The primary difference is the addition of the STERRAD® 100S Short Cycle to the indications for use.

A hydrogen peroxide sterilization chemical indicator cleared under K170321 has been included for monitoring.

	Subject Device	Predicate Device	Comparison of subjectdevice with the predicatedevice
Name of Company	Safe Secure	Safe Secure	Identical
Device Name	Sterilization Tyvek SterilizationPouches	Sterilization Tyvek SterilizationPouches	Identical
Intended use	The device is intended to be used toenclose another medical device, in asingle or double pouch configuration,that is to be sterilized by a healthcare provider	The device is intended to be usedto enclose another medicaldevice, in a single or doublepouch configuration, that is to besterilized by a health careprovider	Identical
Material Composition	Tyvek and PET/PE Film MedicalDouble Side Tape (for self-seal pouchesonly)	Tyvek and PET/PE Film MedicalDouble Side Tape (for self-sealpouches only)	Tyvek and PET/PE FilmMedical Double Side Tape(for self-seal pouches only)
Hydrogen PeroxideChemical IndicatorSupplier	3MTM ComplyTM Hydrogen PeroxideChemical Indicator 1248 (K170321)	NA	NA
Biocompatibility	Materials and biological evaluationsCytotoxicity Test (ISO 10993-5) – PostSterilization	Materials and biological evaluations– Post Sterilization: CytotoxicityTest (ISO 10993-5)Pre-Sterilization: Cytotoxicity (ISO10993-5), MaximizationSensitization (ISO 10993-10),Irritation/Intracutaneous Reactivity(ISO 10993-10)	Both were non-cytotoxicpost sterilization.
Configuration	Single pouch configuration withchemical indicator	Single pouch configuration withchemical indicator	Identical
Configurations/Dimensions	Various	Various	Same - bothhave variousconfigurations

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	Subject Device	Predicate Device	Comparison of subjectdevice with the predicatedevice
Design	Adhesive laminated film is a clear, highstrength material; UncoatedTyvek is compatible withsterilization, resistant to microbialpenetration, and resistant to puncture	Adhesive laminated film is a clear,high strength material; UncoatedTyvek is compatible withsterilization, resistant to microbialpenetration, and resistant topuncture	Identical
DeviceConstruction	Self-seal and heat seal pouches:front and back materials are heatsealed together on three sides; fourthside (end) remains open for filling;end is sealed by heat (heat sealpouches) or by removing protectiveliner strip, folding along the pre-fold, and pressing to the film (self-seal pouches). Heat seal tubing:front and back materials are heatsealed together on two sides; twoends are open for selecting size andfilling; ends are sealed by heat.	Self-seal and heat seal pouches:front and back materials are heatsealed together on three sides;fourth side (end) remains openfor filling; end is sealed by heat(heat seal pouches) or byremoving protective liner strip,folding along the pre-fold, andpressing to the film (self- sealpouches). Heat seal tubing: frontand back materials are heatsealed together on two sides; twoends are open for selecting sizeand filling; ends are sealed byheat.	Identical
Materials	Clear laminated PET/LDPE or LDPE-EVA film (front) and uncoated HDPETyvek (back)	Clear laminated PET/LDPE orLDPE-EVA film (front) anduncoated HDPE Tyvek (back)	Identical
Package Integrity	Seal strength, microbial barrier,burst, and peel opencharacteristics meet ISO andASTM requirements	Seal strength, microbialbarrier, burst, and peel opencharacteristics meet ISO andASTM requirements	Identical
Pouch Types	Self-seal pouch; Heat seal pouch; Heatseal tubing	Self-seal pouch; Heat seal pouch;Heat seal tubing	Identical
Shelf Life	2 years from date of manufacture forhydrogen peroxide chemical indicator	5 years for EO chemical indicator	The hydrogen peroxide CIhas a two year shelf life.
Validated for use inSterilization System	Validated to be used withhydrogen peroxidesterilization, EO and SteamSterilization	Validated to be used with EOand Steam Sterilization	The new CI isvalidated to be usedwith hydrogenperoxide sterilization
Chemical Indicator	Hydrogen Peroxide CI attached tooutside of pouch	EO or Steam CI attached tooutside of pouch	The new CI isvalidated to be usedwith hydrogenperoxide sterilization

Summary of Non-Clinical Testing

This section includes a brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission to support a determination of substantial equivalence.

Test	Description		Result
PackageIntegrity	Seal Strength Test	ASTM F88/F88M-15
	Seal Leak Test	ASTM F1929-15	Pass
	Sterilization Chemical Indicator Test and Visual Inspection	Visual examination
MaterialCompatibility	Seal strength test, microbial barrier properties, burst test, and peel open test were studied todemonstrate material compatibility characteristics of the Tyvek Sterilization Pouches		Pass
Biocompatibility	Not direct patient-contacting devices; Materials are non-toxic. Biological evaluations meetacceptable criteria; Provides reasonable assurance for safety. Standards referenced include: ISO10993-1 and ISO 10993-5.		Pass
Shelf Life	Physical properties and microbial barrier of the processed Tyvek Pouches was verified at theend of shelf life of 2 years		Pass

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Test	Description	Result
Sterilization Validation	Full, half, and partial/fail cycles were used to validate the cycle. The following standards were used in the submission. Standards referenced include: ISO 11140-1, ISO 11138, ISO 14161	Pass
Chemical Indicator	Testing was performed to demonstrate compliance to Submissions for Chemical Indicators - Guidance for Industry and FDA Staff as applicable under K170321	Pass

Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device cleared under K153540.

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).